Executive Director Quality, Cell & Gene Therapy
$244,800–$367,200 year
On-siteBoston, Massachusetts, United States
Job Summary
Define and execute the long-term Cell & Genetic Therapies Quality strategy aligned with corporate objectives, building scalable operating models to support portfolio growth and global commercialization. Lead quality readiness from early development through commercialization, establishing roadmaps for innovative therapeutic programs and managing technical risk mitigation plans. Oversee quality oversight for internal sites and external CRO/CMO operations, serving as executive sponsor for health authority inspections and regulatory interactions. Drive enterprise-wide quality transformation, digital innovation, and talent development while managing annual operating budgets and resource planning. Represent Quality in CGT governance to contribute to business, network, and program decisions, ensuring compliance across the drug life cycle.
Required Qualifications
- Master's degree or PhD in Biotechnical/Lifescience discipline or relevant comparable background
- 15+ years of quality/technical experience in pharmaceutical development and commercial manufacture
- 10+ years in a management/supervisory role
- In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics
- Broad and deep technical and compliance expertise in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing
- Current knowledge of industry trends and best practices in Cell/Gene therapies
- Proven expertise / experience with strategies for gene- and cell therapy products, regulatory documentation preparation and inspections
- Demonstrated strategic planning and execution skills required for operational effectiveness and compliance
- Demonstrated leadership supporting late-stage development, commercialization, and marketed products
- Significant experience leading quality organizations across global manufacturing networks and external partners
- 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
- Must be able to lift 50 lbs
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