Director, Supply and Distribution Quality

Responsibilities

• Provide Quality ownership and leadership for commercial packaging and labeling activities performed by CMOs and CPOs
• Serve as the Quality relationship owner for packaging and labeling partners, including governance, performance monitoring, and investigation oversight
• Review final batch/packaging records and make final batch dispositions/release to market
• Act as the Quality lead for storage, transportation, returns, destruction, and distribution activities
• Lead Quality readiness for commercial launch across 3PL onboarding, distribution-lane qualification, and mock recall capability
• Lead the company's DSCSA Quality compliance program and ensure requirements are incorporated into the QMS
• Establish controls for authorized trading-partner verification, electronic transaction-data exchange, serialization, and aggregation
• Own and continuously improve company procedures governing packaging quality, distribution quality, and product traceability
• Lead company inspection readiness and provide Quality representation for FDA, state licensing authority, and Board of Pharmacy inspections
• Establish functional strategy, priorities, and performance indicators aligned with launch and ongoing commercial supply objectives

Requirements

• Bachelor's degree in life sciences, engineering, pharmacy, supply chain, or a related discipline
• Minimum 10 years of progressive commercial pharmaceutical or biotechnology GMP Quality Assurance experience
• Demonstrated experience overseeing CMOs, CPOs, 3PLs, distributors, or other external supply partners
• Strong working knowledge of pharmaceutical cGMP, packaging and labeling controls, commercial distribution quality systems, DSCSA, and applicable Good Distribution Practice principles
• Experience with supplier oversight, quality agreements, audits, quality events, CAPA, change control, and inspection readiness
• Experience with serialization, traceability-data exchange, suspect-product processes, or related product-security controls
• Demonstrated ability to make risk-based Quality decisions and influence senior leaders
• Experience with distribution of Controlled Substances
• Ability to travel approximately 15%

Preferred Qualifications

• Experience with commercial product launch, 3PL implementation, and distribution-lane qualification
• Experience with serialization or traceability platforms
• Experience supporting FDA, state Board of Pharmacy, or other regulatory inspections
• Experience with small-molecule oral solid dosage products
• Familiarity with state pharmaceutical licensing, NABP programs, EPCIS, or artwork-management platforms

About the Company

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric and neurological disorders by applying scientific rigor to psychedelics.