BioSpace

Lead design and optimization of cloud-based quality management and analytics systems. | Senior engineer with cloud development, AI/analytics, and regulated environment experience. | About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube. Job Description The Operations Quality Senior Systems Engineer will investigate,identify, and implementstate-of-the-arttechnology platforms, focusing on Quality Management Systems (QMS), Learning Management Systems (LMS), Document Management Systems (DMS), Artwork Management Systems, and advanced Data & Analytics solutionsleveragingAI. This role acts as a senior technical leader to integrate technical advances into business solutions that drive productivity, compliance, and operational excellence across Quality and Operations. Responsibilities - Lead the design, operation, and optimization of large-scale cloud services (AWS) supporting QMS, LMS, DMS, artwork, and data analytics platforms. - Troubleshoot complex system issues and tune performance for enterprise-scale applications. - Architect and develop robust, scalable, and fault-tolerant cloud-native solutions using REST APIs, microservices, and containerized technologies. - Create andmaintainAgile, test-driven development workflows for regulated systems, ensuringGxPand compliance requirements. - Manage the full software development lifecycle, including version control (git), CICD pipelines, testing, and regional cloud deployments for quality and operational platforms. - Ensure adherence to AbbVies Corporate and Divisional Policiesregardingcode of conduct, safety,GxPcompliance, data security, and the SDLC. - Conduct technology assessments, proofs-of-concept, and evaluations of emerging solutionsespecially AI/MLto enhance quality operations and automate business processes. - Implement security best practices and collaborate with cross-functional teams, including QA, IT, Regulatory, and Business stakeholders. - Engineer platform-as-a-product solutions offering self-service capabilities for business users across quality, operations, and compliance. - Integrate generative AI and analytics into enterprise applications to enable intelligent automation, predictive quality monitoring, and enhanced user experiences. - Leverage AWSexpertisetoarchitect solutions that are high-performance, cost-optimized, and reliable for global operations. Qualifications Required: - Bachelor's Degree with 6 years relevant experience;Masters Degree with 5 years experience; PhD with 0 years experience. - Extensive hands-on experience developing and deploying applications in AWS or Azure cloud - Demonstratedtrack recordof creative technology implementations that have advanced quality oroperationsbusiness outcomes. - Strong working knowledge of the SDLC (waterfall and agile). - Experience with Java or other modern programming languages (Python, Node.js, etc.). - Demonstrated understanding and delivery of AI and analytics. - Excellent written and oral English communication skills for technical and non-technical audiences. - Experience in running technology evaluations and assessments for regulated environments. Preferred - PhD with industry experience preferred, ideally within pharmaceutical, medical devices, or life sciences. - Knowledge and understanding of quality system requirements (GxP, FDA, ISO 9001), and regulatory technology practices. - Hands-on experience developing and deploying applications in QMS, LMS, DMS, and related systems. - Technology certifications highlypreferred;AWS certificationsa plus Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: - The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this roleat thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on manyfactors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture. - We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. - This job is eligible toparticipate in our short-term incentiveprograms. Note: No amount of payis considered to bewages or compensation until such amount isearned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat areallocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Companys sole and absolutediscretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Lead end-to-end product value chain strategy and execution ensuring supply reliability and compliance. | Requires 8-12+ years in materials management, 5-10+ years in GMP pharmaceutical operations, and 2-5+ years leading global matrix teams. | Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Director, Value Chain Product LeaderFully remote role, travel dependent on business need, Candidates must be based in the USThe Value Chain Product Leader is accountable for designing, operating, and continuously improving a best in class, end to end value chain that reliably connects patients to medicines. This role provides focused, end-to-end accountability for the product value chain within a defined scope, ensuring alignment to product strategy, enterprise standards, and regulatory requirements. As a matrix leader, the Value Chain Product Leader leads the Product (s) functional Value Stream Team (VST) and represents Supply Chain on TOPS Product Teams (TPTs) for assets on development. The role ensures a compliant, robust, resilient, and cost-effective supply chain across clinical and commercial stages of the product lifecycle. The Value Chain Product Leader proactively manages risk, drives lifecycle and network strategies, and leads mitigation when patient level supply risks are identified, including supply assessments that inform Global Issue Management and regulatory notification decisions. : Key Accountabilities End-to-end Value Chain Ownership • Own the design, performance, and continuous improvement of the product value chain, aligned to enterprise strategy and standards. • Ensure reliable supply of quality products to patients across clinical and commercial stages. • Deliver products to markets in accordance with defined service and lead time targets. Product Lifecycle & Strategy Execution • Drive the product lifecycle management roadmap, optimizing lead time, cost, and resilience. • Define and execute product and network strategies, including flow of goods, SKU strategy, and inventory strategy. • Identify and champion strategic investments required to support growth, resilience, and long-term sustainability. Risk Management & Business Continuity • Proactively identify, assess, and communicate risks impacting product quality, compliance, patient supply, and business continuity. • Lead mitigation strategies and escalation for actionable supply risks, including patient-level stockout scenarios. • Own business continuity, supply chain efficiency, and agility plans to ensure program objectives are met. Financial & Performance Management • Own inventory health, key supply chain cost drivers, and trade‑offs between service, cost, and risk. • Ensure accurate product costing, including development and maintenance of standard costs. • Enable data driven, risk-based decision making across the value chain. Governance & Business Partnership • Serve as the primary voice of the product in relevant business forums, including brand reviews, regional reviews, and portfolio governance. • Define the target operating model for the product value chain, including roles, processes, and decision rights across Planning, Manufacturing, Quality, Logistics, and external partners. • Build strong strategic partnerships with Commercial, Clinical, Technical Operations, and Enterprise functions. Leadership Responsibility • The Value Chain Product Leader is a matrix leader responsible for leading cross functional teams accountable for executing product value chain strategies within their respective functions. • The role provides coaching and development to team members on product and value chain requirements, monitors performance against deliverables, and provides feedback to functional management on individual performance and development needs. Key Interfaces • TOPS Product Teams • Supply Planning & Demand Planning • Clinical Supply Chain Operations • Commercial & Clinical Operations • Manufacturing & Material Operations • Procurement & Category Management • Enterprise Master Data Management • Legal, Tax, Product Costing & Finance • Logistics (Cold Chain, Warehousing & Distribution) • Product Development & Formulation • Packaging Development & Validation • Environmental Health & Safety • Global Trade Compliance • Quality Control & Quality Assurance • Qualified Person / Responsible Person • Product Artwork & Launch Management Minimum Requirements • Bachelor’s degree (BS/BSc) in life sciences, engineering, supply chain, or business administration, with 8–12+ years in materials management/production planning/scheduling, 5–10+ years in GMP/GCP compliant pharmaceutical operations, and 2–5+ years leading global, cross functional, matrixed teams. • Strong supply chain and value chain management expertise, ERP expertise (Oracle or SAP preferred), pharmaceutical regulatory frameworks (GMP, ICH), risk and project/program management. • Demonstrated capability to assess issues across Regulatory, Quality, Supply Chain, and Manufacturing perspectives • Executive‑level communication, influence‑based leadership, cross‑cultural/global execution, strategic and operational thinking, continuous improvement and process excellence mindset • Willingness to travel internationally as required. Nice to Have • MBA (Supply Chain, Finance, or Business Operations preferred) • APICS or equivalent supply chain certification • Lean / DMAIC certification (Green Belt or higher) • PMP or equivalent project management certification • Biopharmaceutical operations experience • Strong financial and business acumen • Advanced regulatory and GMP expertise, including ICH Q8–Q12 Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An 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.

Lead technical design and delivery of campaign planning and automation platforms, integrating multiple systems to enable multi-channel marketing campaigns. | Requires 7+ years in campaign orchestration or related domain with 2+ years technical leadership, strong system integration and architecture skills, and experience in complex matrixed organizations. | If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. How We Work - The Global Capability Product Operating Model: At Jazz, we are reimagining how we design and deliver more precise customer experiences, enabled by new technologies, modern ways of working, and high performing team behaviors. Through this work, we enable teams to better understand patients, caregivers, and HCPs, anticipate their needs across the enterprise, deliver timely and personalized engagement, and orchestrate seamless, end-to-end experiences as One Jazz. To power this ambition with both speed and scale, we are embracing a new capability-oriented operating model, allowing business and technology teams to partner side by side in building, advancing, and delivering global capabilities across our enterprise. Cross-functional, empowered Global Capability teams own outcomes—not just outputs—and work from clear capability visions, strategies, and measurable goals. We prioritize user problems, validate solutions through experimentation and data, and iterate quickly to create real value for our users and the business. As part of this model, you’ll collaborate closely with users, stakeholders, and technical teams across the organization, using discovery and delivery practices to ensure we’re building the right things, in the right way, at the right time. The Tech Lead, Campaign Planning & Automation, provides hands-on technical leadership and solution design expertise for the Campaign Planning Global Capability team within the Campaign Orchestration team. Reporting to the Technical Suite Lead, Campaign Orchestration, Content Development & Deployment, this role serves as the primary technical leader for the capability, partnering closely with the Global Capability Owner, Activation Lead, development teams, and/or vendor teams to ensure capability priorities and global standards.  The Campaign Planning team delivers campaign planning and execution capabilities that enable audience targeting, campaign activation, and coordinated engagement across marketing channels. As the Tech Lead, this role is a hands-on contributor and technical leader, directly involved in designing, building, and delivering solutions for Campaign Planning & Automation platforms supporting campaign execution, audience management, and multi-channel engagement alongside the development team, bringing technical depth and leadership to every stage of the work. Essential Functions/Responsibilities Key Responsibilities: Strategy & Technical Roadmap Development • Partner closely with the Campaign Planning & Automation Global Capability Owner to design solutions that solve business problems, providing technical insight on what the technology can and cannot do, effort levels, and tradeoffs. • Convert complex business requirements into clear technical specifications and executable technical work tasks. Solution Architecture & Technical Delivery • Lead the technical team and drive work plans, building, configuration, and integration of software aligned to business needs and technology standards, including: • Campaign Planning platforms, enabling campaign configuration, execution, and orchestration across marketing channels. • Audience management and segmentation capabilities, supporting targeting, list generation, and campaign audience activation. • Integration with CRM, data platforms, and analytics systems to enable seamless campaign execution, tracking, and performance measurement. • Translate technical requirements into well‑defined work for the development team, lead agile ceremonies, and ensure disciplined execution of the capability roadmap, taking ownership of complex technical challenges end to end. • Guide development teams in campaign configuration, automation workflows, and execution frameworks that enable scalable and efficient campaign delivery across channels. • Enable seamless integration between campaign platforms, CRM systems, and data sources to support accurate audience targeting and campaign execution. • Support audience segmentation, list management, and campaign activation processes to ensure campaigns are executed effectively and at scale. • Support the optimization of campaign performance by monitoring execution, delivery metrics, and engagement outcomes, continuously improving campaign effectiveness and operational efficiency. Cross-Functional Technical Leadership • Partner with business, IT security, and vendor teams to ensure the Campaign Planning team technical solutions adhere to organizational standards, security policies, and regulatory requirements. • Organize and direct vendor partners to execute technical work, ensuring alignment with capability priorities, delivery timelines, and enterprise standards. • Partner with the Technical Suite Lead, Campaign Orchestration, Content Development & Deployment, to escalate and resolve complex technical challenges that span across Global Capability teams. • Mentor and guide software engineers and developers, elevating the team's overall technical capability. • Lead cross-team problem solving and resolution of technical challenges within the Global Capability team. Required Knowledge, Skills, And Abilities Technical Skills • Experience designing, testing, deploying, operating, and enhancing scalable, secure, and compliant technology solutions for large scale organizational use. • Understanding of enterprise software architecture, cloud platforms, and modern engineering frameworks. Knowledge of system integration patterns, APIs, and data architecture across enterprise technology platforms. • Experience owning tools for campaign planning, marketing automation logic, campaign execution, and campaign/tactic metadata management as enterprise systems of record. Strong understanding of cross-channel campaign planning workflows, marketing automation technologies and journeys built inside them, campaign execution platforms and related metrics. • Strong understanding of campaign orchestration logic, segmentation and targeting, consent enforcement and preference management, and marketing CRM governance. • Ability to design scalable, reusable campaign frameworks and activation patterns. Experience integrating CRMs, orchestration, analytics, and customer data platforms. • Ability to partner with teams to translate executive and Commercial requirements into scalable, well-governed technology solutions with roadmaps and prioritization. Provide technical leadership on standardization, KPI implementation, and architectural trade-offs to ensure enterprise technology assets remain consistent, performant, and extensible across brands and regions. • Experience leading mixed teams of internal developers and vendors, including technical direction, code and dashboard reviews, estimation, and delivery accountability. Proven ability to collaborate with UX researchers and UI designers, with user-centric mindset applied to technical development. • Experience working within Agile product development teams and product operating models. Business Skills • Customer Journey Understanding – ability to see customer’s end-to-end experience clearly and use it on an ongoing basis for go to market strategic, tactical and measurement decisions, while anticipating needs across touchpoints. Make practical decisions that improve journey and outcomes. • Cross functional Matrix Collaboration – ability to work fluidly across teams and reporting lines respecting SME, coordinating shared work, ensuring progress even when accountability is distributed – supporting decisions with professional alignment and focus on collective success. Deeply understands and values unique capabilities and perspectives of diverse functions. • Systems Thinking - The ability to understand how actions create upstream and downstream effects across the organization, seeing patterns and interdependencies to improve the whole ecosystem, not just individual parts. • Adoption — ability to quickly embrace new tools, new WoW, and behaviors applying with confidence and practical improvement • Continuous Improvement — ability to regularly improve processes/products through reflection and iteration, generates new options and approaches when constraints exist, growth mindset, challenges status quo Qualifications Required/Preferred Education and Licenses • Bachelor's degree in computer science, engineering, information systems, or related technical field. • 7+ years of experience after Bachelor's degree (or 5+ years of experience after Master's degree) in campaign orchestration, omnichannel engagement digital marketing operations, or related domains in pharma. • 2+ years of experience as a Tech Lead, Technical Program Manager, Engineering Manager or similar role involving hands-on technical leadership of a development team. • Experience working within complex, matrixed organizations with multiple technology and product teams. • Proven ability to mentor and guide developers and vendor partners to deliver high-quality solutions. Preferred / Additional Qualifications • Experience in pharmaceutical or healthcare industries preferred. • Experience partnering with enterprise platform teams or Global Capability teams supporting digital and operational capabilities. • Experience working in rare disease or specialty brands, with strong understanding of unique stakeholder dynamics. Working Requirements 10-20% travel will be required. Jazz Expected Behaviors  • Demonstrates ownership and accountability, taking responsibility for outcomes and driving work forward with urgency, clarity, and a focus on impact.  • Leads with curiosity and a Growth Mindset, actively exploring user needs, emerging technologies, and new ways of working to elevate capability and innovation.  • Embraces change as a learning opportunity, adapting quickly, modeling resilience, and helping others navigate dynamic environments.  • Acts with a One Jazz mindset, prioritizing enterprise value, breaking down silos, and building strong, trust-based partnerships across teams.  • Delivers high performance results, setting ambitious goals, challenging assumptions, and consistently driving measurable business impact.  • Models inclusive, collaborative leadership, creating space for diverse perspectives and empowering others to contribute their best work.  • Invest in continuous learning, developing personal skills while coaching and elevating the capabilities of colleagues and cross functional partners.  • Navigates ambiguity with confidence, using sound judgment, data, and user insights to make informed decisions even when information is incomplete.  • Communicates with clarity and influence, simplifying complexity, aligning stakeholders, and ensuring shared understanding of priorities and outcomes.  Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $141,600.00 - $212,400.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.