Quality Site Head
Core
Lead the Quality organization for a manufacturing and testing facility, ensuring compliant product supply and operational excellence for clinical and commercial operations.
Role type
Senior GMP Quality Site Head
Builds
Commercial and clinical pharmaceutical products
Domain
Pharmaceutical manufacturing and quality control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP quality systems leadership, regulatory compliance (FDA/EMA/ICH), risk management, inspection readiness, validation oversight, talent management, strategic planning
Preferred skills
Experience with facility expansion and commercialization, cross-functional partnership, organizational development
Technologies
GMP quality systems, computerized systems, laboratory operations
Responsibilities
Drive strategy and operations for the site Quality organization; Serve as senior decision-maker for compliance, investigations, and risk management; Ensure compliant testing and release of commercial and clinical product; Lead GMP functions including QA, QC, validation, and inspection readiness; Provide leadership for facility start-up, commissioning, and technology transfer; Partner cross-functionally with Manufacturing, Engineering, and Regulatory Affairs; Maintain inspection readiness and lead regulatory interactions; Oversee quality work products like deviations, CAPAs, and data integrity; Develop organizational capability through talent management and succession planning; Build a high-performing Quality organization for expanding operations.
Seniority
Senior, hands-on IC with strategic leadership
