Associate Director, Quality Change Management

Role: Lead change control governance within a biopharma setting, ensuring risk-based assessments, compliance, and high-quality change execution across internal operations and external partners. Responsibilities: establish change control standards, coordinate cross-functional reviews, manage performance metrics, and maintain inspection readiness; partner with CMC, MSAT, Supply Chain, and Quality teams for tech transfers and lifecycle changes. Requirements: BS in Science or Engineering; 10-12 years of GMP QA/QMS experience with demonstrated leadership in change management; proficiency with eQMS tools like Veeva Vault. Preferred: experience with post-approval change governance, external manufacturing, and workflow optimization. HighValue: focus on quality governance, lifecycle change management, regulatory compliance, and inspection readiness in a biopharma environment. WorkSetup: Not specified; travel requirements are not mentioned.