Executive Director Quality, Cell & Gene Therapy
Core
Strategic leader defining and executing the Cell & Gene Therapy (CGT) Quality vision, operating model, and organizational strategy to ensure quality readiness from early development through commercialization.
Role type
Executive Director, CGT Quality
Builds
Scalable, inspection-ready quality capabilities across internal manufacturing sites and external partner networks for life-changing therapies.
Domain
Biotechnology / Cell & Gene Therapy / Pharmaceutical Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (Quality strategies, operating models, compliance roadmaps)
Required skills
Global health regulatory agency knowledge (GXP life cycle), Cell & Gene therapy technical expertise, Aseptic manufacturing technology, Analytical assays, Process validation, Risk management, Strategic planning, Organizational leadership, Budget management
Preferred skills
Digital quality innovation, Talent development, Stakeholder alignment
Technologies
GXP frameworks, Digital quality tools
Responsibilities
Define and execute long-term CGT Quality strategy aligned with corporate objectives; Lead quality governance for PPQ, process validation, and commercial readiness; Establish quality oversight for internal sites and external CRO/CMO operations; Build and develop a high-performing global quality organization; Drive enterprise-wide quality transformation initiatives.
Seniority
Executive, Strategy & Organization Building
