Director, Supply and Distribution Quality

Role: Lead Quality for commercial supply, overseeing outsourced packaging, labeling, distribution, and product traceability for a late-stage biopharmaceutical company developing psychedelics and neuropsychiatric therapies. Responsibilities: provide Quality oversight of CMOs, CPOs, 3PLs, and distribution partners; ensure compliance with cGMP, DSCSA, and Good Distribution Practices; manage quality readiness for product launch and lifecycle, including serialization, change control, and inspection readiness; lead investigations of product security and traceability issues; establish risk-based governance and monitor partner performance. Requirements: minimum 10 years' GMP Quality Assurance experience in pharma/biotech, with proven oversight of external manufacturing and distribution partners; strong knowledge of pharmaceutical packaging, distribution, serialization, and regulatory compliance; leadership skills to influence cross-functional teams and external stakeholders; experience with controlled substances preferred. HighValue: commercial distribution, serialization, DSCSA compliance, supply chain risk management, inspection readiness, and experience with small-molecule oral solid products. WorkSetup: travel approximately 15%, with increased travel during launch phases or inspections.