Director, GMP Quality Assurance

Role: Director of GMP Quality Assurance overseeing global quality operations for development and commercial biopharmaceutical products. Responsibilities: manage quality assurance for finished products from early development through commercialization, including clinical and commercial distribution compliance, batch review, and product release; lead investigations, change controls, risk assessments, and oversight of GMP and GDP activities; author and review technical and regulatory documentation supporting submissions and inspections; ensure compliance with global regulations such as FDA, EU GMP, and DSCSA; interface with regulatory authorities and oversee third-party audits. Requirements: Bachelor's in a scientific discipline; 10+ years in pharma/biotech, with 8+ years in GMP QA; extensive knowledge of GMP/GDP regulations, CMC, process validation, and global supply chain; experience supporting regulatory submissions, inspections, and international contract manufacturing; strong leadership, communication, and risk management skills. HighValue: GMP QA leadership, global distribution compliance, product lifecycle support from early development to commercialization, experience with serialization and traceability, regulatory interaction, and inspection readiness. WorkSetup: travel up to 20%, including international.