Executive Director Quality Assurance, External Manufacturing
Core
Leading external manufacturing quality strategy and governance across a global network of CDMOs to ensure GMP compliance, supply continuity, and regulatory readiness for clinical and commercial vaccine supply.
Role type
Executive Director, Quality Assurance (External Manufacturing)
Builds
Clinical and commercial vaccine supply via external CDMO partners
Domain
Biopharmaceuticals / Vaccines / Contract Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations expertise, CDMO oversight, risk-based quality management, inspection readiness, technology transfer, process validation, executive influence, organizational development
Preferred skills
Vaccine experience, complex problem solving, strategic leadership
Technologies
GxP systems, risk management frameworks
Responsibilities
Own quality performance across the external network ensuring compliance and supply continuity; Provide end-to-end QA leadership for externally executed GxP activities; Establish and maintain strategic partnerships with external partners; Lead quality governance including KPIs and risk-based oversight; Oversee resolution of complex cross-organizational quality issues; Provide oversight for batch disposition and product release; Drive inspection readiness for global health authorities; Provide strategic QA leadership for technology transfer and lifecycle management; Build and develop a high-performing External Quality organization.
Seniority
Executive Director, strategic leadership with hands-on oversight
