Director, Commercial Supply Quality

The Director, Commercial Supply Quality is a critical hire responsible for overseeing Quality operations across outsourced commercial packaging, labeling, storage, transportation, distribution, serialization, and product traceability activities. This role ensures compliance with cGMP, Good Distribution Practice principles, the Drug Supply Chain Security Act (DSCSA), and approved procedures while supporting launch readiness and ongoing supply.

Working collaboratively with Quality, Supply Chain, Pharmaceutical Development, Regulatory Affairs, Trade & Distribution, Information Technology, and external partners, the Director establishes risk-based governance, manages 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.