[Hiring] Director, Supply and Distribution Quality @Definium Therapeutics

Role Description

The Director, Commercial Supply Quality is the Quality lead for outsourced commercial packaging, labeling, storage, transportation, distribution, serialization, and product-traceability activities. This role is a critical hire that will support readiness of launch stock and ongoing supply.

This role provides Quality oversight of contract manufacturing organizations (CMOs), contract packaging organizations (CPOs), third-party logistics providers (3PLs), distributors, carriers, and related technology providers. The Director ensures that the commercial supply network operates in compliance with cGMP, applicable Good Distribution Practice principles, the Drug Supply Chain Security Act (DSCSA), approved procedures, and quality agreements.

Working across Quality, Supply Chain, Pharmaceutical Development, Regulatory Affairs, Trade & Distribution, Information Technology, and external partners, the Director establishes risk-based governance, supports commercial launch and ongoing supply, manages significant quality and product-security risks, and maintains inspection readiness across the external network.

Responsibilities

• Commercial Packaging & Labeling Quality
  • Provide Quality ownership and leadership for commercial packaging and labeling activities performed by CMOs and CPOs from launch readiness through post-approval lifecycle management.
  • Serve as the Quality relationship owner for packaging and labeling partners, including governance, performance monitoring, quality-event escalation, investigation oversight, CAPA follow-up, and product-impact assessment.
  • Provide Quality approval of packaging artwork and labeling components for GMP compliance, version control, implementation accuracy, reconciliation, and change control; Regulatory Affairs retains approval of regulatory content.
  • Oversee Quality readiness and lifecycle management for outsourced packaging and labeling, including artwork implementation, component qualification, line trials, process validation, serialization, reconciliation, and change control.
  • Reviews final batch/packaging records and makes final batch dispositions/release to market.
• Distribution, Logistics & 3PL Quality
  • Act as the Quality lead for storage, transportation, returns, destruction, and distribution (including reverse logistics) activities performed through the outsourced commercial network.
  • Lead Quality readiness for commercial launch across 3PL onboarding, distribution-lane qualification, returns processing, traceability-data exchange, mock recall capability, and initial market supply.
  • Establish risk-based oversight of 3PLs, distributors, carriers, depots, storage facilities, transportation lanes, equipment, and supporting systems, including qualification, validation, performance monitoring, periodic review, and inspection readiness.
  • Oversee logistics-related quality events, including temperature excursions, shipment damage, loss, theft, diversion, security events, and delivery exceptions; and coordinate investigation, product-impact assessment, escalation, and disposition with functional area owners.
  • Serve as the Supply Quality lead for recalls, mock recalls, distribution holds, market actions, and returns; including management of any resulting dispositions.
• DSCSA, Serialization & Product Traceability
  • Lead the company’s DSCSA Quality compliance program and ensure that requirements applicable to the company’s role in the pharmaceutical distribution supply chain are incorporated into the Quality Management System.
  • Establish controls for authorized trading-partner verification, electronic transaction-data exchange, serialization, aggregation, verification, exception management, reconciliation, and record retention.
  • Provide Quality governance for serialization and traceability platforms in partnership with Supply Chain and Trade & Distribution.
  • Lead or oversee suspect and illegitimate product investigations, including quarantine, verification, trading-partner communication, disposition, corrective action, and required regulatory notification.
  • Monitor evolving regulatory requirements and industry standards and translate applicable changes into procedures, training, partner expectations, and readiness plans.
• Quality Systems, Partner Governance & Inspection Readiness
  • Own and continuously improve company procedures governing packaging quality, distribution quality, product traceability, returns, suspect product, and related quality events.
  • Serve as the Quality relationship owner for in-scope commercial supply partners while working through the company’s established supplier qualification, audit, approved-supplier, and quality-agreement processes.
  • Provide quality representation for recurring external partner meetings and leads quality portion of business review meetings.
  • Lead company inspection readiness and provide Quality representation or partner-site support for FDA, state licensing authority, Board of Pharmacy, and other inspections involving packaging, distribution, traceability, or DSCSA processes.
  • Ensure significant quality events across the commercial supply network are promptly escalated, investigated, assessed for product and compliance impact, and addressed through effective corrective and preventive actions.
  • Track, trend, and report meaningful quality and compliance indicators to senior leadership and Management Review, including partner performance, shipment exceptions, traceability exceptions, investigations, CAPAs, and recurring risks.
• Leadership & Cross-Functional Partnership
  • Establish functional strategy, priorities, performance indicators, and resource plans aligned with launch and ongoing commercial supply objectives.
  • Influence internal stakeholders and external partners through clear governance, risk-based decision-making, and effective escalation.

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 programs.
• 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.

Preferred Qualifications

• 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 and some fun fringe perks!