Executive Director Quality, Cell & Gene Therapy

Position Summary:

• Executive leader defining and executing the CGT Quality vision, operating model, and organizational strategy; ensure quality readiness from early development through commercialization; build scalable, inspection-ready quality capabilities across internal sites and external partners.

Responsibilities:

• Define and execute long-term CGT Quality strategy; build scalable quality operating models; drive enterprise-wide quality transformation.
• Lead/represent Quality in Cell & Genetic Programs; partner to support health authority requests and market authorization submissions.
• Oversee process and analytical technical transfers; lead CGT quality and technical risk management and mitigation plans.
• Develop integrated digital quality capabilities for proactive quality management.
• Ensure quality readiness through commercialization and lifecycle management; establish launch and global expansion quality strategies; lead quality governance for PPQ, process validation, comparability, and readiness activities.
• Establish quality oversight for internal and CRO/CMO operations (manufacturing/distribution); serve as executive sponsor for health authority inspections; lead internal/external partner compliance and operational excellence.
• Build and develop global quality organization; succession planning and talent development; foster inclusive continuous-improvement culture; manage budgets/resources/organizational design and strategic investments.

Qualifications:

• Education: Master’s degree or PhD in biotechnical/life science (or comparable background).
• Experience: 15+ years in quality/technical experience in pharmaceutical development and commercial manufacture; 10+ years in management/supervisory role.

Required Skills/Knowledge:

• In-depth global regulatory knowledge across GxP lifecycle in cell/gene therapy and/or biologics.
• Deep expertise in cell technology, aseptic manufacturing, analytical assays, processing, fill/finish, and testing.
• Experience with gene/cell therapy regulatory documentation and inspections; strategic planning/execution; leadership across global manufacturing networks; risk management, critical thinking, and strong communication/influencing.