Vertex Inc.

Compensation

Full Description

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.