14 open positions available
Support marketing technology platforms to enhance customer engagement and ensure compliance with privacy regulations. | Experience with marketing technology platforms, especially CDP and MA, and healthcare/biopharmaceutical industry knowledge. | Job Description General Summary: Vertex is seeking a talented leader to join our North America Commercial Operations team to support our growing portfolio of transformational therapies. This role will be part of the Digital Customer Engagement team that will support other core marketing technology platforms and will drive the evolution and implementation of our innovative go-to-market model that focuses on a lean in-person presence supplemented by robust digital engagement. This individual will will work with marketing teams to ensure our CDP & MA platforms deliver an optimized customer experience across the patients & healthcare professionals we seek to engage. We are seeking a candidate that has a strong experience and background in marketing technology with a specific focus on scaled digital customer engagement. This candidate should have experience working in commercial business units, and have the ability to thrive in a fast-paced, innovation-driven environment. This role is remote eligible and reports to the Director, Digital Customer Engagement in Commercial Operations. Key Duties and Responsibilities: Collaborate with cross-functional teams, including marketing, sales and DTE (IT), to ensure the product aligns with business needs and technical requirements Develop use cases aligned to marketing team objectives and drive consensus with relevant internal stakeholders to align on feasibility and implementation plan Ensure maintenance of detailed product backlog, including user stories, epics, and acceptance criteria, in collaboration with the development team Support the definition and measurement key performance indicators (KPIs) to assess the product's success and support data-driven decisions for continuous improvement Provide training and support to internal teams and customers to maximize the value of the marketing automation platform Manage expectations and feedback acting as a bridge between stakeholders to ensure effective communication of product updates and milestones effectively Participate in all aspects of agile process including sprint planning and retrospective meetings to ensure efficient development cycles and prioritized features based on business and customer needs Provide strategic input that helps manage the relationship with the MA & CDP vendors to evaluate potential platform updates or upgrades and recommendations on their implementation. Ensure compliance with relevant data protection and privacy regulations in the implementation of marketing automation features (e.g., HIPAA) Stay informed about industry trends, emerging technologies, and best practices in CDP & MA to identify opportunities for innovation Foster a culture of innovation, teamwork, and customer-centricity within the product team and across the organization Cultivate strong partnerships with cross-functional teams to support business goals and engage above role including close partnership with the field, patient, disease education and program counterparts, serving as a peer leader on the marketing and launch readiness teams Role models and instills a culture of compliance focused on ethics and integrity in all we do Education and Experience 5+ years of work experience working with marketing technology platforms with a specific focus on CDP and MA technology platforms Healthcare/biopharmaceutical experience is strongly preferred Experience establishing and gaining cross-functional and leadership alignment on a marketing technology product vision, roadmap and implementation plan in a matrixed organization Ability to effectively translate commercial business requirements into articulate functional requirements to ensure alignment on stated business objectives across teams Entrepreneurial spirit and courage to challenge the status quo to develop innovative and focused approaches to enable launch through data and technology, regular measurement of results and pivoting based on our test and learn strategy Strong written and verbal communication skills, with the ability to connect with senior leaders as well as more varied large audiences Comfortable working in a highly collaborative and results-driven environment within a growing business unit where we are concurrently learning & building as we drive towards product launch Demonstrated understanding of the legal, regulatory, privacy, and compliance requirements within the life sciences industry specific to the use of marketing technology platforms Travel Requirements: Ability to travel 10 - 20% Pay Range: $0 - $0 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Assist in developing, executing, and optimizing customer-facing websites to support commercial engagement. | Requires 5+ years leading customer web site delivery, digital skills, and vendor management experience. | Job Description General Summary: The Web Operations Senior Manager assists in the development, execution, and optimization of customer facing web sites used by commercial teams to engage patients, caregivers, healthcare providers, and payers. This role will work with commercial teams, information technology, multiple vendors and agencies to help ensure the organization's processes, personnel, budget, and platforms are operating effectively to support the commercial business needs in the US. Key Duties and Responsibilities: Assists in identifying current and future gaps in the commercial organization's ability to engage customers through websites Works with internal and external stakeholders to prioritize web site initiatives Ensures roles and responsibilities are clearly documented and communicated to ensure effective delivery of digital programs Creates, executes, and communicates performance management plans to continuously improve the digital operating model Identifies and manages external agencies and vendors supporting website development Supports the growth of digital skills throughout the commercial organization Knowledge and Skills: Developing, launching, and optimizing web sites Managing internal and external partner relationships Measurement of digital programs Web content management Significant skills in digital program budget development and management Education and Experience: Typically requires 5 years of work experience leading the delivery of customer web sites to promote products and services to external customers, or the equivalent combination of education and experience Pay Range: $0 - $0 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Lead and mentor engineering teams to develop high-performance SaaS products, architect AI-driven solutions, and optimize system performance. | Extensive experience in software and performance engineering, cloud-native SaaS applications, AI/ML initiatives, and leadership in technical roles. | Job Description: Lead Software Engineer Job Summary Are you a software engineering technical leader looking to drive the performance and scale for market leading SAAS products? Join us as we turn vision into reality! The ideal candidate is passionate about providing software engineering solutions applied to performance engineering delivery where business outcomes are our playground. About Us At Vertex, we build the technology that keeps global commerce moving. Every transaction, every return, every compliance calculation—our systems are trusted by thousands of the world’s most complex businesses. As we scale our SaaS platform and products, we’re engineering for extreme performance, precision, and resilience across diverse customer workloads. We are investing deeply in AI‑driven engineering, using intelligent automation, advanced LLMs, and performant architectures to transform how our products are built and operated. Engineers here don’t just write features—they solve high‑leverage systems problems, model and optimize performance at scale, and design automation that becomes force multipliers for entire value streams. Our teams are collaborative, curious, and serious about their craft. We value people who take ownership, push boundaries, and elevate those around them. We foster an environment where engineers can stretch, lead, and continuously deepen their expertise—whether in distributed systems, performance engineering, or cutting‑edge AI. If you’re driven to build systems that truly scale, to solve meaningful engineering challenges, and to grow your career while shaping the future of intelligent performance automation, you’ll thrive here. Key Responsibilities Technical Leadership: Apply software and performance engineering practices to architecture, and technology choices that lead to high performing, scalable solutions. Lead and mentor junior engineers, guide technical design and architecture discussions with a performance by design approach. Build Transformative AI Solutions: Drive tangible outcomes through hands-on implementation for the end-to-end technical delivery of performance engineering AI solutions by creating or leveraging data for ingestion by LLMs with NLP APIs to accelerate performance testing and delivery outcomes. Accountability: Take primary ownership of designing, developing, and personally implementing high-quality performance engineering solutions. A significant part of this will involve architecting and deploying complex AI and Large Language Model (LLM) based intelligent agents and automated workflows, all built to deliver automation and performance engineering outcomes. Become a Trusted Strategic Partner: Embed yourself deeply with value stream engineering teams to truly grasp their performance needs, challenges and strategic product goals. You'll translate these nuanced needs into clear, actionable technical performance goals and solution designs, building strong relationships as their primary performance advisor and leading performance discussions and optimizing features. Proactively Remove Technical Blockers: Identify, analyze, and directly resolve complex technical performance challenges during all phases of release delivery, from planning, design, to sophisticated performance test automation and advanced agent orchestration. You'll be the ultimate go-to expert for driving value stream product performance. Development: Design, code (hands-on), and maintain (proactive monitoring, troubleshooting) software solutions using object-oriented or modern languages (C#, Java, Go etc.) Test: Create test scenarios and design, develop, and execute corresponding automated tests. Cloud Infrastructure: Experience with major cloud providers like AWS, Azure or GCP. Understanding of Infrastructure as Code (e.g. Terraform, CloudFormation, Helm etc.) Collaboration: Excel in global cross-functional teams, including product management, senior leaders, engineering and architecture. Code Reviews: Utilize code reviews to ensure code quality, performance and maintainability, as well as mentoring opportunities. Continuous Improvement: Champion a culture of continuous improvement by driving engineering excellence, conducting root cause analyses, and implementing feedback loops to enhance code quality, team productivity, and system reliability. Qualifications Education: Master’s degree (preferred) or bachelor’s degree in computer science, engineering, or a related field (or equivalent experience). Experience: 8 - 10 years in a combination of software and performance engineering, with at least 3 years in Cloud Native SaaS applications and preferably 2-3 years mentoring and coaching engineers in a leadership role. Experience working on AI/ML initiatives or certifications in AI technologies is a strong plus. Knowledge of queueing theory and performance models (USL, Little’s Law, Amdahl’s Law) a plus. Technical Skills Experience in object-oriented/modern languages (C#, Java, Go etc.) Proven ability to lead technical engagements, mentor junior team members, and oversee technical aspects of projects Proven ability to implement and drive performance test methodologies, principles, patterns, and practices across multiple parallel initiatives Demonstrated accountability, a "get-things-done" attitude, and a focus on fast, impactful delivery, with a proven ability to lead technical initiatives Proficient in RESTful API, Open API design and development, and database technologies (RDBMS, NoSQL). Proficiency with CI/CD pipelines, containerization (Docker, Kubernetes) and infrastructure as code (Terraform, CloudFormation, etc.). Experience in designing and implementing scalable test automation strategies using modern frameworks and tools such as k6, Locust, JMeter., with integration into CI/CD pipelines (e.g., GitHub Actions, Azure DevOps, Jenkins) and cloud-based testing platforms. Experience designing and delivering AI solutions using modern software engineering practices and cloud technologies (e.g., Azure, AWS, GCP), with a strong focus on Generative AI and Large Language Models (LLMs). Understanding of security best practices and frameworks. Knowledge of Snyk is a plus. Excellent communication, interpersonal, presentation, and facilitation skills across time zones. Our Core Values: Here are the Winning Way behaviors that all Vertex employees embrace every day: Own the Outcome: Commit to milestones and demonstrate unwavering support for team decisions. If you are unsure, ask! Work with Purpose: Foster a "We Can" mindset where results outweigh effort; everyone understands how their roles contribute to team outcomes. Act with Urgency: Adopt an agile mentality with a focus on quick iterations and resilience. Communicate with Clarity: Be clear, concise, and actionable. Embrace constructive feedback. Drive to Decision: Make decisions swiftly with defined deadlines and accountability. Pay Transparency Statement: US Base Salary Range: $138,800.00 - $180,400.00 Base pay offered to new hires may vary based upon factors including relevant industry and job-related skills and experience, geographic location, and business needs.* The range displayed does not encompass the full potential of the role, which allows for further growth and career progression. In addition, as a part of our total compensation package, this role may be eligible for the Vertex Bonus Plan (VOB), a role-specific sales commission/bonus, and/or equity grants. Learn more about Life at Vertex and connect with your recruiter for more details regarding Vertex's compensation and benefit programs. *In no case will your pay fall below applicable local minimum wage requirements. Join our Talent Community to stay updated on the latest job opportunities, news, and events tailored to your career interests. Vertex is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you'd like to view a copy of the company's affirmative action plan, please email AskHR@vertexinc.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact 610-640-4200 or AskHR@vertexinc.com. This telephone line and email address is reserved solely for job seekers with disabilities requesting accessibility assistance or an accommodation in the job application process. Please do not call about the status of your job application if you do not require accessibility assistance or an accommodation. Messages left for other purposes, such as following up on an application or non-disability related technical issues, will not receive a response.
Develop and execute omnichannel digital marketing strategies for healthcare products, leading cross-functional teams and leveraging data analytics. | Extensive experience in digital campaigns, healthcare engagement, and team leadership, with familiarity in CRM and analytics tools. | About the position General Summary: The Senior Director, Omnichannel Marketing - U.S. Kidney will lead the development and execution of omnichannel strategies to support the launch and growth of Vertex’s kidney portfolio. This role will shape the digital customer experience across HCP and patient audiences, leveraging data-driven insights to optimize engagement and impact. Responsibilities • Develop and own the US digital marketing strategy for the kidney portfolio, including launch planning, content strategy, and channel optimization. • Lead cross-functional collaboration with brand, medical, legal, and agency partners to deliver compliant, compelling digital assets. • Develop a comprehensive digital strategy and roadmap to achieve business impact goals. • Leverage data-driven insights to create tailored strategies that resonate with target audiences and reinforce brand positioning. • Work closely with the marketing team to maintain consistent messaging, tone, and visual identity across all digital touchpoints. • Monitor campaign performance, analyze data, and translate findings into actionable recommendations to continuously improve effectiveness and maximize ROI. • Stay current on healthcare industry digital trends, emerging technologies, competitor activities, and market dynamics to drive innovation and differentiation. Requirements • Proven success in leading digital campaigns for product launches or major brand initiatives, overseeing strategy and content development. • Deep understanding of HCP and patient engagement in the US healthcare landscape. • Strong leadership, communication, and project management skills. • Ability to navigate matrixed environments and influence cross-functional stakeholders. • Familiarity with CRM platforms, marketing automation, and digital analytics tools. • Experience managing agencies and external partners. • Strategic mindset with hands-on execution capability. • Effective communication skills, both verbal and written to negotiate internally/externally often at higher levels. • Ability to successfully navigate and lead a team in a fast-paced, matrixed environment. • Bachelor's degree in marketing, business or a science discipline. • Typically requires 12 years of experience in pharmaceutical or biotechnology and at least 5 years of digital strategy experience. • Previous supervisory/management experience required. Nice-to-haves • Experience in nephrology or specialty care preferred. Benefits • This role is eligible for an annual bonus and annual equity awards. • Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. • At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. • From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Manage GMP quality operations, batch disposition, and compliance activities in a Cell & Gene Therapy manufacturing environment, ensuring regulatory adherence and operational excellence. | Requires 8+ years in pharmaceutical quality operations, with management experience and deep knowledge of GxP regulations in biologics or cell therapy manufacturing. | Job Description General/Position Summary Senior Manager, GMP Quality Operations is a technical resource in the principles and application of quality assurance and compliance. The Sr. Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. The role is responsible for maintaining documents reconciliation, labeling control, master batch records and issuance of batch records for production. The quality senior manager is responsible for implementing strict issuance tracking, controlling version updates, and ensuring data integrity (ALCOA+) to prevent unauthorized changes and ensure product safety The role will closely partner with operational stakeholders to lead product disposition activities and resolution. A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders for advancing quality outcomes and operational excellence. Key Duties & Responsibilities Author SOP's to support commercial quality functions. Assist with regulatory agency inspections Ensuring that Master Batch Records are managed to maintain compliance over the life cycle. Identify and facilitate continuous improvement efforts Managing the issuance of BPRs, ensuring only authorized, current versions are printed for production. Maintaining logs for the issuance, return, and reconciliation of batch records to prevent misuse and ensure accountability. Ensure audit readiness: Maintaining organized, accessible documentation for regulatory inspections Establishment of quality oversight for internal quality and external CDMO operations for the batch disposition process, across development, launch and commercial manufacturing. Manage the day-to-day timely release of finished product to ensure compliance with Regulatory and Vertex cGMP requirements. Assure disposition activities across CGT Therapy related products manufacturing are compliant and consistent. Develop, establish, and implement Batch disposition operational Quality and Compliance metrics. Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions. Identify and communicate risks and assist with risk mitigation plans as necessary. Represent Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning. Participate and lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions. Lead and mentor other team members, support development of organizational capabilities and talent building. Manage the department resources with regards to budget and personnel. Build strategic relationships with internal and external partners – CDMOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary. Required Education Level Bachelor's degree or Masters degree relevant comparable background. Required Experience 8+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment Required Knowledge/Skills In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (EU GMPs, FDA 21CFR Part 1271, GxPs). Broad and current knowledge of batch disposition industry trends and best practices in Cell/Gene therapies. Preferred QA Operational experience for Autologous Cell Therapy Operations. Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing. Demonstrated strategic planning and execution skills required for operational effectiveness and compliance. Proven ability with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma. Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence. Ability to apply risk management principles to decision making and operational priorities. Critical Thinking and Problem Solving skills Ability to closely collaborate and build relationships with internal and external stakeholders. Other Requirements Up to 15% Travel may be required #LI-onsite Pay Range: $136,400 - $204,600 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Provide quality oversight for validation, calibration, and maintenance programs, lead investigations, and support regulatory inspections at Vertex CGT sites. | Requires 8+ years in a regulated pharmaceutical environment with deep knowledge of GxP, validation, and cell & gene therapy processes. | Job Description General/Position Summary The Senior Manager, Quality Assurance Technical Services will execute and provide quality support and oversight for Quality Engineering and Validation programs at Vertex Cell and Genetic Therapies sites. This role is responsible for executing QA activities for validation of equipment and systems, facility and equipment change controls, CAPAs, validation-related deviations, and all validation lifecycle documentation. Furthermore the role will support the calibration and Maintenance program QA oversight activities. Acting as a trusted advisor, the Senior Manager will collaborate with site operation business partners to ensure compliance, address quality issues, and drive continuous improvement. This is a 5 days on site role located in the Seaport, Boston. Key Duties & Responsibilities Provide quality oversight and ensure compliance with standards across internal Vertex CGT manufacturing sites. Execute the validation QA activities for drafting, review, approval and execution of validation documents. Support return-to-service cleaning, testing, and GMP release of facilities/equipment for change controls. Execute calibration and Maintenance program QA activities. Review and analyze program effectiveness, identifying gaps and opportunities for improvement. Lead quality event investigations, root cause analysis, and corrective actions. Support return-to-service cleaning, testing, and GMP release of facilities/equipment for change controls. Partner with cross-functional teams to ensure timely completion of periodic trend reports and implementation of corrective actions. Monitor and track performance metrics, presenting them at Quality forums, site leadership and management review forums. Execute on calibration and maintenance program QA oversight activities. Collaborate with project teams to ensure alignment and timely resolution of issues. Participate and provide compliance oversight for quality systems, including change controls, deviation investigations, CAPA, and effectiveness checks. Conduct risk identification, gap analysis, and implement robust corrective actions. Lead or participate in process optimization workstreams and continuous improvement initiatives. Participate in inspection readiness activities and support regulatory site inspections including act as quality SME for facility control programs and post inspection activity execution. Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals. Required Education Level Batchelor's degree or Masters degree or relevant comparable background. Required Experience 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment Required Knowledge/Skills In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (EU GMPs, FDA 21CFR Part 1271, GxPs). Broad knowledge and current experience of equipment, facilities and utility validation industry trends and best practices in a cGMP Cell/Gene therapies. Preferred QA Operational experience for Autologous Cell Therapy Operations. Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing. Demonstrated strategic planning and execution skills required for operational effectiveness and compliance. Proven ability with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma. Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence. Ability to apply risk management principles to decision making and operational priorities. Critical Thinking and Problem Solving skills Ability to closely collaborate and build relationships with internal and external stakeholders. #LI-onsite Pay Range: $136,400 - $204,600 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Lead the global digital experience strategy, oversee AI integration, CRO, and performance analytics, and manage a cross-functional team to optimize digital platforms. | Over 10 years of experience in digital experience leadership, proven success in global website strategy, expertise in SEO, AI, CRO, and team governance, with strong analytical and strategic skills. | This a Full Remote job, the offer is available from: United States Job Description: Key Responsibilities Digital Experience Strategy & Leadership • Define and execute the global digital experience strategy focused on discoverability, engagement, conversion efficiency, and digital performance. • Establish a scalable global operating model that supports multilingual experiences, regional needs, and enterprise-wide brand and experience consistency. • Translate business objectives and audience insights into digital experiences that improve visibility, navigation, content quality, and relevance across global markets. • Provide strategic oversight of the external development and UX agency and set experience requirements, partnering with the Marketing Technology team that owns the underlying platform and technical systems. • Oversee digital experience implications of M&A, guiding decisions on consolidation, migration, content harmonization, and experience alignment to maintain a unified global brand and platform strategy. AI-First Digital Experience & GEO Visibility • Embed AI-driven practices across digital experience design, personalization, content modeling, and user journeys. • Lead strategies that ensure discoverability and authority across traditional search, AI-powered search experiences, and Generative Engine Optimization (GEO) surfaces. • Establish standards for structured content, metadata, semantic tagging, modular content, and schema to improve visibility and answerability within AI engines and LLMs. • Partner with marketing teams and Analytics partners to monitor and enhance Vertex’s presence across AI search, AI answer surfaces, and LLM citation environments. Conversion Rate Optimization (CRO) & Experimentation • Own the CRO strategy for global digital properties, improving conversion across key pathways (product exploration, content engagement, demo/consult requests, solution journeys). • Build and manage an experimentation roadmap using A/B and multivariate testing to improve page-level and journey-level performance. • Partner with analytics, UX/design, content, and campaign teams to identify friction points and implement optimization experiments that improve usability, clarity, and conversion uplift. • Establish scalable frameworks for persuasive design, journey optimization, and CRO best practices across the global digital experience. Performance, Insights & Optimization Frameworks • Define advanced measurement frameworks for the global digital experience, focusing on discoverability, content engagement, user intent, journey effectiveness, experience friction, and conversion pathways. • Direct the development of dashboards and reporting that surface actionable insights on content performance, experience quality, path efficiency, behavioral patterns, and AI-driven visibility. • Integrate behavioral analytics, search/AI insights, UX findings, and user feedback loops into prioritized, ongoing optimization roadmaps. • Ensure global alignment with accessibility standards, UX best practices, content quality expectations, and digital governance requirements. • Identify and track advanced experience metrics (e.g., navigation depth, content affinity, AI citation velocity, search-to-engagement ratios) to inform ongoing optimization and personalization. Cross-Functional Leadership & Collaboration • Collaborate with global content, SEO, digital marketing, marketing technology, analytics, and demand teams to drive unified digital strategies and execution. • Ensure the global website effectively supports demand programs and campaign strategies by aligning experience pathways with audience needs and buying stages. • Communicate vision, priorities, and optimization recommendations clearly to senior leadership. • Serve as a senior advocate and educator for AI-first digital experience practices and emerging digital trends. Team Leadership & Governance • Lead the global Web Operations team responsible for digital experience implementation, optimization, and governance. • Define roles, responsibilities, and operating rhythms that support high-quality execution and global collaboration. • Develop global governance frameworks for UX, content standards, structured data, AI tagging, metadata, accessibility, and localization practices. • Implement scalable processes that support continuous delivery, experimentation, and innovation across all web initiatives. • Foster a culture of excellence, accountability, creativity, and data-informed decision-making. Qualifications • 10+ years leading digital experience, website strategy, or digital transformation in a global B2B or SaaS organization. • Proven experience owning or leading a global website, digital program, or digital operations team. • Deep expertise in digital strategy, user experience, structured content, SEO/GEO visibility, and AI-influenced discoverability. • Demonstrated success building and leading CRO programs and experimentation frameworks. • Experience building and leading global teams and governance models. • Strong analytical, strategic, and communication skills with the ability to influence senior leaders and global stakeholders. Familiarity with accessibility, privacy, and digital compliance standards across global markets. Pay Transparency Statement: US Base Salary Range: $157,900.00 - $205,400.00 Base pay offered to new hires may vary based upon factors including relevant industry and job-related skills and experience, geographic location, and business needs.* The range displayed does not encompass the full potential of the role, which allows for further growth and career progression. In addition, as a part of our total compensation package, this role may be eligible for the Vertex Bonus Plan (VOB), a role-specific sales commission/bonus, and/or equity grants. Learn more about Life at Vertex and connect with your recruiter for more details regarding Vertex's compensation and benefit programs. • In no case will your pay fall below applicable local minimum wage requirements. This offer from "Vertex Inc." has been enriched by Jobgether.com and got a 72% flex score.
Oversee GMP QA operations including batch disposition, ensuring compliance and continuous improvement across manufacturing sites. | Requires 10+ years in pharmaceutical regulated environment, with 5+ years in management, and deep knowledge of GxP life cycle, Cell & Gene therapy, and GMP operations. | Job Description General/Position Summary The Director, Quality Assurance GMP Operations will oversee the GMP QA operations including batch disposition process across CDMOs in the US and Internationally. Responsibilities include day-to day operational quality oversight for internal batch record review operations and QA manufacturing operations from clinical to commercial stage of product globally. The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk mitigation, execution of operational activities participation of governance committees associated with improvements to the disposition process. A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders to drive compliance and continuous improvement activities. The role may support on site internal manufacturing activities. The role is a 5 days on site role at Vertex in the Boston Seaport. Key Duties & Responsibilities Establishment of quality oversight for internal quality and external CTO/CDMO operations for the batch disposition process, across development, launch and commercial manufacturing globally. Proactively drives continuous improvements in processes, identifies and mitigates compliance gaps and drive culture of quality across all operational activities. Manage the day-to-day timely release of finished product to ensure compliance with Regulatory and Vertex cGMP requirements. Represent Quality and serve as a trusted partner for the disposition activities of drug product. Lead and mentor other team members, support development of organizational capabilities and talent building. Assure disposition activities across CDMOs are compliant and consistent. Ensure adequate training to the Department personnel. Manage the department resources with regards to budget and personnel. Build strategic relationships with internal and external partners – CDMOs and CTOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary. Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence. Develop, establish, and implement Batch disposition operational Quality and Compliance metrics. Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits. Establish/participate and lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions. Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions. Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals. May be required to support manufacturing on site activities. Required Education Level Bachelor's degree or Master's degree or equivalent Required Experience 10+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment Required Knowledge/Skills In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (EU GMPs, FDA 21CFR Part 1271, GxPs). Broad and current knowledge of batch disposition industry trends and best practices in Cell/Gene therapies. Preferred QA Operational experience for Autologous Cell Therapy Operations. Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing. Demonstrated strategic planning and execution skills required for operational effectiveness and compliance. Proven ability with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma. Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence. Ability to apply risk management principles to decision making and operational priorities. Critical Thinking and Problem Solving skills Ability to closely collaborate and build relationships with internal and external stakeholders. Other Requirements Up to 15% Travel may be required #LI-onsite Pay Range: $184,600 - $277,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Lead standardization of financial processes, develop financial models, and support strategic decision-making for Disease Strategy Teams. | Requires 8+ years in FP&A, Strategy, or Analytics, with strong financial modeling, biopharmaceutical knowledge, and stakeholder communication skills. | Job Description The Senior Manager, DST Finance is a key member of Vertex's Disease Strategy Finance Team, providing financial and strategic insights to inform Disease Strategy Teams (“DSTs”) on key decisions. This role will work closely with the Senior Director, DST Finance to lead standardization in financial reporting and analytics across DSTs as well as develop cross-Disease Area financial analyses. The Senior Manager will play a critical role in ensuring financial modeling, forecasting, and scenario-based valuation integrate with enterprise-wide financial planning processes. Key Duties and Responsibilities: Lead standardization of DST Finance processes to ensure consistent level of rigor, balance, and transparency for businesses cases, stage-gate reviews, and investment proposals. Lead development and maintenance of reporting tools to communicate financial impact of business cases and integration into regular financial processes. Collaborate with DST Finance leads to develop and maintain disease area-, asset-, and indication-specific financial models. Represent DST Finance across the organization with specific focus on enterprise financial processes, including planner meetings for Budget, Long-Range Plan, and Forecasts. Partner with Global Financial Systems team to develop self-service reporting and tools for high-frequency deliverables. Proactively identify and drive opportunities for process improvement that enhanced decision-making support for Disease Strategy Teams. Represents DST Finance as a center of excellence for all modeling, valuation and ad hoc analysis used for a wide range of decisions, including presentations at Executive Committee level meetings. Support integration of external innovation into DST Finance processes and workflows. Ad-hoc support for Business Development modeling, valuation, and forecasting. Basic Requirements: Bachelor’s degree in finance, Business, Economics or Accounting required. MBA and/or other advanced degree preferred. 8+ years of experience in FP&A, Strategy, or Analytics roles Important Knowledge and Skills: Deep understanding of, and demonstrated curiosity to learn, biopharmaceutical drug discovery, development, manufacturing, regulation, and commercialization. Expert analytical and financial modeling skills to evaluate a broad range of financial questions – especially valuation and strategic planning. Ability to work independently to answer business questions or create ad-hoc reporting that may be needed. Expertise with Excel and strong PowerPoint skills; experience with Hyperion or other multidimensional database; experience with business intelligence and visualization tools a plus. Excellent communication and presentation skills, with the ability to influence stakeholders at all levels and a proven ability to present complex financial insights to senior stakeholders. “Internal consultant mindset” with ability to solve problems through pragmatic, creative approaches and leadership to implement ideas through to successful conclusion. Strong communication skills, both written and verbal, and an eagerness to collaborate with colleagues (within or outside of finance) in sharing insights and learnings and partnering to ensure timely execution of project plans. Possesses a continuous improvement mindset, with flexibility and ability to adapt to change. #LI-HYBRID Pay Range: $134,400 - $201,600 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Develops and executes partner ecosystem strategies to drive revenue growth and manages relationships with partner organizations. | Requires extensive experience in partner management, SaaS, ERP, and sales, with a focus on high-level relationship building and strategic planning. | Job Description: This position is responsible for the Partner Ecosystem (e.g. ERP/eCommerce) GTM strategy and annual Plan. This role is focused on driving business relationships at all levels of the partner organization, leveraging these relationships for revenue growth within various sales channels. The Partner Development Manager will collaborate partner strategy and activities with executive, sales, marketing, development, partner and product leadership and other internal functional teams as required to execute on appropriate Partner strategy and go-to-market plans. This role is accountable for driving ecosystem pipeline working in a cross-functional team to achieve the annual net new revenue goal for the assigned Partner Ecosystem. ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES: Drives partner business development strategy and activities with Partner globally in support of corporate revenue and strategy goals. Develops, cultivates, and leads Partner Ecosystem relationships for partner and business- related activities that drive opportunities to meet annual revenue target. Interacts with all levels of the Partner Ecosystem leadership (executive, solutions, partner, development, and sales) to maintain and grow existing partner relationships. Develops, fosters and extends a network of executive relationships across the Partner Ecosystem. Manages Partner Ecosystem channel planning and operational activities - partner strategy, market development, business planning, and forecasting. Executes the company's go-to-market plans related to Partner objectives and sales goals. Creation of Partner Ecosystem annual account plan and provides quarterly updates for executive management. Collaborates with the organization's Sales Channel Managers to drive awareness through the partner and sales ecosystem. Properly positions Partner solution messaging through the Partner Ecosystem customer channel. Initiates and drives participation at industry and/or partner events (user groups, associations). Promotes the organization's solutions through the channel and generate additional product and services demand through trade shows, webcasts, demos, etc. Addresses industry groups through public speaking, presentation development and delivery, etc. Provides Partner leadership through social media venues that build market awareness. Provides support to Vertex global sales and channel teams activities. Develops and open relationships with appropriate Partner sales and channel leadership. Provides subject matter expertise in pre-sales activities (either directly or directing team resources) - participating on sales conference calls, meetings and in RFP processes. Promotes and supports Partner education internally, coordinating knowledge transfer, training, and facilitating Vertex operational readiness. Monitors Partner Ecosystem to assess the sales impact of Vertex solution(s) in the marketplace and the overall success of the partner. Monitors competitor activity in the Partner Ecosystem and implements strategies to maintain account ownership and block competitor advancement. Ensure Vertex Alliances are aware, trained and supported on Partner integrations with Vertex solutions and products. Provides mentorship to new and existing members across the partner program. Participates in projects and performs other duties as assigned. Occasional business travel may be required. SUPERVISORY RESPONSIBILITIES: N/A KNOWLEDGE, SKILLS AND ABILITIES: Deep working knowledge of SaaS and tax technology applications (ERP, eCommerce, Procurement technologies). Ability and experience to operate effectively at senior management and C-executive levels internally and externally. Partner business plan formulation and execution experience. Ability to manage a portfolio of partner solutions that has potential to drive a minimum of $5 million in new annual revenue. Develop and execute annual partner go-to-market plan to achieve annual objectives and revenue quota for specific Partner Ecosystem. Demonstrates leadership ability to work in a cross-functional go-to-market team environment. Demonstrate team leadership and team building skills. Ability to coordinate/lead industry and/or partner special interest group meetings. Strong market knowledge of the ERP/Ecommerce ecosystem. Strong acumen of the end-to-end business transaction process between host application and Vertex. Strong knowledge of partner strategy with ability to communicate impact to Vertex. Strong business acumen and execution skills, financially astute. Strong communication and presentation skills both written and verbal. Demonstrate ability to gain trust and credibility across Partner and Vertex organizations. Ability to succeed in a collaborative environment. Ability to build base case to gain organizational alignment for new Partner initiatives. Ability to manage high visibility or high impact projects simultaneously. Ability to work with minimal supervision. Ability to listen and understand information and communicate the same. Must possess strong interpersonal, organizational, presentation, facilitation and negotiation skills. Must be results oriented and customer focused. Self-motivated, accountable approach and a strong sense of teamwork. Takes initiative to drive/improve internal partner business processes for the betterment of the team. Ability to listen and understand information and communicate the same. Must possess good organizational skills. Must be results oriented, customer focused, and exhibit good interpersonal skills. Proficiency in Microsoft office packages. EDUCATION AND TRAINING: Bachelor’s Degree in Business required; MBA preferred. Ten (10) plus years of experience in partner management and/or sales or business development within a business software preferred. Or equivalent combination of education and/or experience. Other Qualifications The Winning Way behaviors that all Vertex employees need in order to meet the expectations of each other, our customers, and our partners. • Communicate with Clarity - Be clear, concise and actionable. Be relentlessly constructive. Seek and provide meaningful feedback. • Act with Urgency - Adopt an agile mentality - frequent iterations, improved speed, resilience. 80/20 rule – better is the enemy of done. Don’t spend hours when minutes are enough. • Work with Purpose - Exhibit a “We Can” mindset. Results outweigh effort. Everyone understands how their role contributes. Set aside personal objectives for team results. • Drive to Decision - Cut the swirl with defined deadlines and decision points. Be clear on individual accountability and decision authority. Guided by a commitment to and accountability for customer outcomes. • Own the Outcome - Defined milestones, commitments and intended results. Assess your work in context, if you’re unsure, ask. Demonstrate unwavering support for decisions. COMMENTS: The above statements are intended to describe the general nature and level of work being performed by individuals in this position. Other functions may be assigned, and management retains the right to add or change the duties at any time. Pay Transparency Statement: US Base Salary Range: $131,600.00 - $171,100.00 Base pay offered to new hires may vary based upon factors including relevant industry and job-related skills and experience, geographic location, and business needs.* The range displayed does not encompass the full potential of the role, which allows for further growth and career progression. In addition, as a part of our total compensation package, this role may be eligible for the Vertex Bonus Plan (VOB), a role-specific sales commission/bonus, and/or equity grants. Learn more about Life at Vertex and connect with your recruiter for more details regarding Vertex's compensation and benefit programs. *In no case will your pay fall below applicable local minimum wage requirements. Join our Talent Community to stay updated on the latest job opportunities, news, and events tailored to your career interests. Vertex is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you'd like to view a copy of the company's affirmative action plan, please email AskHR@vertexinc.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact 610-640-4200 or AskHR@vertexinc.com. This telephone line and email address is reserved solely for job seekers with disabilities requesting accessibility assistance or an accommodation in the job application process. Please do not call about the status of your job application if you do not require accessibility assistance or an accommodation. Messages left for other purposes, such as following up on an application or non-disability related technical issues, will not receive a response.
Provide end-to-end quality oversight for small molecule programs throughout their lifecycle, ensuring compliance with industry standards and regulatory requirements. | Minimum 8 years in pharmaceutical or biopharmaceutical industry with experience in quality, regulatory, or process development, and leadership in cross-functional teams. | Job Description The Product Quality Associate Director is accountable for end-to-end quality oversight of small molecule program(s) throughout clinical development, commercialization, filing, approval, launch, and post-approval lifecycle management activities. This oversight includes setting and maintaining overall Quality strategies in support of commercialization efforts including establishing relevant product quality standards for current or novel technologies (including devices where applicable), ensuring QA and cross-functional alignment with industry and regulatory expectations, identifying product quality risks and mitigations throughout the development lifecycle of the assigned program, through commercialization and decommissioning. The candidate should have a good understanding of drug development and commercialization and be able to partner effectively with development functions (i.e., process development, analytical development, manufacturing science and technology, site QA/QC, and regulatory CMC) and commercial functions (i.e., AS&T, MS&T, QC, QA Operations, Supply Chain) to enable a robust product development (Quality by Design - QbD) approach that considers technical, regulatory, and quality / compliance considerations per cGMP regulation. The candidate will ensure a robust supply chain and support product launch activities per program needs. The candidate will foster strong collaboration and partnership with external and internal stakeholders, and the international Quality leadership team. This individual will provide strategic guidance and direction to the integrated benchmarking and external environmental monitoring for identifying emerging industry trends and best practices to facilitate maximum value to evaluation of the health of the quality system. Key Duties & Responsibilities Provide clearly defined Quality expectations, Quality strategy, and Quality deliverables for the assigned program(s) within the Vertex product portfolio, including in-licensed and outsourced products, as part of commercialization and product lifecycle management. Develop, approve, and maintain critical Quality standards and control requirements for products and processes (e.g., stage gate deliverables, product specifications, stability program development), working in collaboration with key internal and external stakeholders, embedding the principles of product lifecycle and QbD. Ensure quality and compliance frameworks, guidance, and systems are in place to keep them current with general industry and health authority expectations as well as Vertex’s QMS. Critically evaluate new products and processes with respect to Quality and compliance requirements. Work with development functions and supply chain to improve manufacturing processes, new product introduction standards, and overall program strategy and keep them current with global regulatory expectations and internal Vertex standards, integrating the scientific intent of the technical SMEs and clinical phase-appropriate approaches, as applicable. Proactively identify Quality risks and improvement opportunities for the assigned program(s) across all stages of manufacturing and across all drug product presentations in support of commercialization. Ensure that the identified risks, mitigations, and possible improvements are understood by CMC development team stakeholders by working with project teams and stakeholders to mitigate them during clinical development, validation, submission, and launch. During lifecycle management of a product, support post-approval changes due to continuous improvement, regulatory requirements or commitments, geo-expansion strategy, and business driven reasons. Proactively identify Quality risks and product quality issues and support post-approval changes to mitigate these risks by partnering with the commercial manufacturing project teams and stakeholders. Ensure significant Quality risks are escalated per the company procedure and properly mitigated in a timely manner by working with the cross-functional/site teams. Champion a consistent approach to Quality and compliance standards as they relate to product, recognizing the wider implications of Quality-related issues, including the implementation of the principles of Quality by Design and new and emerging regulatory guidance. May serve as a single point of Quality contact for new product introduction and PAI readiness for the assigned product(s) on the CMC product and/or project governance teams covering Analytical Development, Process Development, Technical Operations, and Supply Chain topics for GMP/GDP clinical trial materials and commercial products to ensure a global Quality strategy is developed and maintained for consistency and standardization (to the extent it is practical). Represent Quality at appropriate governance meetings to critically review product strategy, promoting a risk-based approach. Act as a project manager within Quality for the assigned project, ensuring and facilitating effective multi-directional communication between the Quality groups and cross-functional teams and ensuring standardized processes (e.g., new product introduction, risk assessments, technology transfers, etc.) are used. Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving relevant documents per team timeline and associated HA questions on the filing. Support device development for combination products (as needed) by taking part in design history file reviews, strategy, risk identification, and risk mitigation. Define resource allocation for network of QA resource assignment for his/her/their assigned products. Education and Experience Bachelor’s or Master's degree in a Scientific/Technical/Business discipline. Minimum of 8 years of deep and broad experience in a technical, quality, and/or regulatory role within the pharmaceutical/biopharmaceutical industry in product development and associated project management and governance is required. Key areas of preferred expertise are: DS/DP manufacturing, process validation, specification setting, control strategy setting, regulatory submission authoring. A minimum of 3 years in directly managing staff and/or leadership experience in leading cross-functional teams, projects, programs, or directing allocation of resources is preferred. Previous experience on a Site Leadership Team or R&D Leadership Team is strongly preferred. Required Knowledge/Skills Expertise in cGMP compliance, FDA guidelines, and international guidelines dealing with pharmaceutical manufacturing and Quality Assurance, quality standards, policies and procedures. Demonstrated application of the principles of cGMP and Quality Assurance. Experience in the practicalities of implementing 21st century cGMP guidelines, ICH Q8/9/10/11, PAT/ASTM guidance, etc. In-depth understanding of quality processes/systems (e.g., change control, event handling, CAPA), risk management and manufacturing control strategies. Direct experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections). Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member. Demonstrated influential leadership experienced in operating in a matrix organization (across boundaries) with Technical, Supply Chain and Regulatory functional areas through presenting, influencing, negotiation and partnering is required. Capable of building alignment across diverse perspectives and functional areas. Demonstrated strategic thinking capability with strong project management skills and ability to focus on execution of strategic decisions Experience in technology transfer, process development and/or process validation. We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work: 1. Hybrid and work remotely up to two days per week; or select 2. On-Site and work 5 days per week with ad hoc flexibility. #LI-AR1 #LI-Hybrid Pay Range: $151,200 - $226,800 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Oversee quality operations, ensure compliance with GMP standards, lead cross-functional teams, and support regulatory inspections. | Extensive experience in GMP quality management, sterile manufacturing, microbiological procedures, and regulatory agency interactions, with leadership skills in managing teams and complex projects. | Job Description General Summary: The Associate Director, GMP Operational Quality is responsible for quality oversight of QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. The role will also oversee team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams. This role requires collaborative interaction with cross-functional partners such as analytical and process development, clinical and commercial QC, and manufacturing operations to ensure the on-time closure of deviations, CA/PA, and change controls. This QA position will work with internal and external QA teams and QC labs ensuring adherence to compliance while supporting both clinical and commercial release and stability testing of a genetically edited cell therapy product. The position will provide compliance support to both clinical and commercial data review and data management. This person will support QA activities related to GMP release and stability as well as lifecycle improvement for methods related to raw material, in-process, and drug product samples. The GMP-facing nature of this work requires keen attention to detail and understanding of analytical compliance expectations. Key Duties and Responsibilities: Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at Vertex Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms Enable team to achieve team goals/objectives and enable their individual career development Develop and maintain compliant quality processes to support GMP activities Oversee the QA support of Change Controls, GMP investigations and associated CAPAs. Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections. Support review of regulatory submissions, as applicable Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources. Lead and follow up on any QLT action items assigned. Identify and communicate risks and assist with risk mitigation plans as necessary Supports internal audit or external audit programs; assists in preparation of audit responses Provide comprehensive knowledge support for partner and regulatory agency audits Assist management team in budgeting and scheduling Responsible for the following activities related to people management responsibilities: Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding Performance Management (goals, monitoring, reviews); Monitoring /Supporting Employee Engagement and Retention; Succession Planning; Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs. Accountable to provide oversight of day to day team operations Assists with workforce planning/resource modeling and to update through forecasting activities Knowledge and Skills: In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing Demonstrated success in building high-performing teams and skilled at managing team and individual development Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections Supstantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva) Education and Experience: Seven (7) + years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in cGMP related industry, with four (4) or more years of work experience in proven leadership/supervision and experience within a sterile manufacturing site and sterilization activities. Preferred Master's degree or relevant comparable background. Required Experience Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e., process air, water for injection, etc.) Knowledge of standard microbiological procedures (sterility testing, environmental monitoring, bioburden, and bacterial endotoxin testing) Must have experience in ethylene oxide, steam sterilization, and gamma radiation requirements. #LI-onsite Pay Range: $156,600 - $234,800 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Coordinate and execute quality assurance activities, review data for compliance, and support continuous improvement efforts in a cell therapy manufacturing environment. | Requires experience in pharmaceutical or biologics quality assurance, cGMP regulations, and managing investigations and CAPAs. | Job Description General Summary: The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. The role will also have responsibilities associated with QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. This role requires collaborative interaction with cross-functional partners such as analytical and process development, clinical and commercial QC, and manufacturing operations to ensure the on-time closure of deviations, CA/PA, and change controls. This QA position will work with internal and external QA teams and QC labs ensuring adherence to compliance while supporting both clinical and commercial release and stability testing of a genetically edited cell therapy product. The position will provide compliance support to both clinical and commercial data review and data management. This person will support QA activities related to GMP release and stability as well as lifecycle improvement for methods related to raw material, in-process, and drug product samples. The GMP-facing nature of this work requires keen attention to detail and understanding of analytical compliance expectations. Key Duties and Responsibilities: Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions Lead root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified Perform change control assessments and closure approvals Establish and revise Quality Agreements between CMOs/Suppliers and Vertex, as needed Collect data and report on metrics Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills. Lead continuous improvement projects Authors and reviews data, SOPs, COAs, analytical methods, protocols, and reports. Assist with regulatory agency inspections Identify and facilitate continuous improvement efforts Support the lead point of contact for QA activities occurring at multiple contract manufacturing and test organizations, including release & stability testing, method equipment/software validation, and adherence to project timelines. Support QA operations for a gene edited hemoglobinopathy cell therapy product and helps troubleshoot technical aspects of analytical methods related to the release of biologics and cell therapy products. Ensures all external laboratory records adhere to cGMP/GDP expectations. Supports compliance related teams working towards the goal of continuous improvement. Assists with OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence Knowledge and Skills: Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines. Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint Ability manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes Formal project management experience Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences. Able to integrates activities with other groups, departments and project teams as needed. Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions Excellent team player and collaborator Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva) Education and Experience: Bachelor's degree in scientific or allied health field (or equivalent degree) Typically requires 4+ years of experience, or the equivalent combination of education and experience #LI-onsite Pay Range: $118,400 - $177,600 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Onsite Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Supervise medical reviews for ICSRs, ensure compliance, and lead operational strategies in pharmacovigilance. | Requires MD or DO, 10+ years in pharmacovigilance, expertise in PV regulations, and experience with Argus and signal detection. | Job Description Role Summary Supervise medical reviews for ICSRs during both clinical development and post-marketing, managing workflows and oversight to ensure evaluations are timely, accurate, and compliant. Serve as the main contact between operations and global patient safety medical teams. This position will contribute to setting standards, enhancing quality and inspection preparedness, executing vendor management, and working with both internal and external stakeholders to share medical expertise with operations teams and communicate operational regulatory requirements to the medical and PV Science groups. Key Responsibilities Lead the operational strategy and standards for ICSR medical review across all case types. Conduct thorough clinical evaluations, handling complex cases and support prioritization of the medical review workflow. Connect ICSR reviews to benefit–risk assessment, informing signal detection and management activities. Ensure compliance with global regulations and internal procedures; lead QA/QC improvements and enhance inspection preparedness in collaboration with PV Compliance and ICSR Teams. Refine and monitor KPIs/SLAs for medical review timeliness, accuracy, and consistency; drive process enhancements and support automation efforts with both internal and vendor staff. Oversee vendor performance and harmonize medical review training and processes for internal/external teams. Collaborate cross-functionally within GPS to ensure medical insights inform safety reports and risk management plans. Maintain governance documentation and deliver metrics and analyses to leadership. Qualifications MD or DO Required; board certification preferred. 10+ years in Pharmacovigilance, 5+ in global medical review management. Strong knowledge of PV regulations, inspection, and audit processes. Proficient with Argus Safety Database and vendor management/oversight. Experience integrating medical review of ICSRs into signal detection and management. Skills Expert clinical judgment and narrative writing. Deep regulatory and compliance expertise. Proven operational leadership and change management. Systems/data skills, especially Argus and E2B(R3). Effective communicator and cross-functional collaborator. Pay Range: $248,500 - $372,700 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
Create tailored applications specifically for Vertex Inc. with our AI-powered resume builder
Get Started for Free