Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)
Core
Ensuring inspection readiness and compliance for external commercial sites, evaluating quality culture, and driving continuous improvement.
Role type
Senior IC quality compliance and inspection readiness lead
Builds
Inspection readiness programs and operational excellence for external sites
Domain
Biotechnology / Pharmaceutical Quality Compliance
Required skills
inspection management, risk management, regulatory requirements knowledge, Six Sigma, Lean, project leadership, performance indicator analysis
Preferred skills
experience in multiple modalities
Technologies
inspection management tools, risk management frameworks
Responsibilities
Drive identification and resolution of issues, gaps, and risks through collaboration and audits; Support and oversee inspection execution including CAPA closure; Report inspection readiness status and risks to leadership; Foster cross-functional collaboration and trusted partnerships with external sites
Seniority
Senior, hands-on IC
