Director, Supply and Distribution Quality

The role

The Director, Commercial Supply Quality is the Quality lead for outsourced commercial packaging, labeling, storage, transportation, distribution, serialization, and product-traceability activities. This role provides Quality oversight of contract manufacturing organizations, contract packaging organizations, third-party logistics providers, distributors, carriers, and related technology providers.

What you will do

• Provide Quality ownership and leadership for commercial packaging and labeling activities
• Serve as the Quality relationship owner for packaging and labeling partners
• Provide Quality approval of packaging artwork and labeling components
• Oversee Quality readiness and lifecycle management for outsourced packaging and labeling
• 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
• Lead Quality readiness for commercial launch across 3PL onboarding and distribution-lane qualification
• Establish risk-based oversight of 3PLs, distributors, carriers, depots, storage facilities, and transportation lanes
• Oversee logistics-related quality events including temperature excursions, shipment damage, loss, theft, and diversion
• Serve as the Supply Quality lead for recalls, mock recalls, distribution holds, market actions, and returns

Required qualifications

• 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, including leadership of commercial supply, external partner, and cross-functional quality p
• Demonstrated experience overseeing CMOs, CPOs, 3PLs, distributors, carriers, 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, complaints, 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 and external partners without direct operational authority
• Experience working with distribution of Controlled Substances
• Ability to travel approximately 15%, with periodic increases during launch, significant investigations, partner qualifications, or regulatory inspections

Nice to have

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

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and vesting after the turn of the first month after your start date
• Flexible time off
• Generous parental leave
• some fun fringe perks!

About the company

Definium Therapeutics is a late-stage clinical biopharmaceutical company. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.