Director, Supply and Distribution Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership and provide leadership for the quality of commercial packaging and labeling activities carried out by CMOs and CPOs from launch readiness through to post-approval lifecycle management.

• Act as the Quality relationship manager for packaging and labeling partners, which includes governance, performance monitoring, quality-event escalation, investigation oversight, CAPA follow-up, and product-impact assessment.

• Review and approve packaging artwork and labeling components to ensure GMP compliance, version control, implementation accuracy, reconciliation, and change control.

• Supervise the outsourced packaging and labeling readiness and lifecycle management, encompassing artwork implementation, component qualification, line trials, process validation, serialization, reconciliation, and change control.

• Examine final batch and packaging records to authorize final batch dispositions/releases for market.

• Direct Quality oversight for storage, transportation, returns, destruction, and distribution, including reverse logistics.

• Lead the commercial launch readiness process, which includes 3PL onboarding, distribution-lane qualification, returns processing, traceability-data exchange, mock recall capability, and initial market supply.

• Establish risk-based oversight for 3PLs, distributors, carriers, depots, storage facilities, transportation lanes, equipment, and supporting systems.

• Manage logistics-related quality events such as temperature excursions, shipment damage, loss, theft, diversion, security events, and delivery exceptions.

• Serve as the Supply Quality lead for recalls, mock recalls, distribution holds, market actions, and returns.

• Oversee the company’s DSCSA Quality compliance program and ensure applicable requirements are integrated into the Quality Management System.

• Set controls for trading-partner verification, electronic transaction-data exchange, serialization, aggregation, verification, exception management, reconciliation, and record retention.

• Provide Quality governance for serialization and traceability platforms.

• Lead or supervise investigations into suspect and illegitimate products, including quarantine, verification, communication, disposition, corrective action, and regulatory notification.

• Keep track of regulatory requirements and industry standards, translating changes into procedures, training, partner expectations, and readiness plans.

• Own and continuously enhance procedures governing packaging quality, distribution quality, product traceability, returns, suspect products, and related quality events.

• Manage Quality relationships with commercial supply partners through supplier qualification, audit, approved-supplier, and quality-agreement processes.

• Represent Quality in meetings with external partners and lead the quality segment of business review meetings.

• Ensure readiness for inspections and provide Quality representation or partner-site support for FDA, state licensing authority, Board of Pharmacy, and other inspections.

• Ensure that significant quality events are escalated, investigated, assessed for product and compliance impact, and addressed through CAPA.

• Monitor, trend, and report quality and compliance indicators to senior leadership and Management Review.

• Establish functional strategies, priorities, performance indicators, and resource plans that align with launch and ongoing commercial supply objectives.

• Influence internal stakeholders and external partners through governance, risk-based decision-making, and escalation.

⛳️ Requirements

• Bachelor’s degree in life sciences, engineering, pharmacy, supply chain, or a related field.

• A minimum of 10 years of progressive experience in GMP Quality Assurance within the commercial pharmaceutical or biotechnology sectors, emphasizing leadership in commercial supply, external partner, and cross-functional quality programs.

• Proven experience in overseeing CMOs, CPOs, 3PLs, distributors, carriers, or other external supply partners.

• Strong knowledge of pharmaceutical cGMP, packaging and labeling controls, commercial distribution quality systems, DSCSA, and relevant Good Distribution Practice principles.

• Experience with supplier oversight, quality agreements, audits, quality events, CAPA, change control, complaints, and inspection readiness.

• Familiarity with serialization, traceability-data exchange, suspect-product processes, or related product-security controls.

• Demonstrated capability to make risk-based Quality decisions and influence senior leaders and external partners without direct operational authority.

• Experience with the distribution of Controlled Substances.

• Willingness to travel approximately 15%, with potential increases during launches, significant investigations, partner qualifications, or regulatory inspections.

• Preferred: Experience with commercial product launch, 3PL implementation, distribution-lane qualification, mock recalls, and initial market supply.

• Preferred: Experience with serialization or traceability platforms.

• Preferred: Experience supporting FDA, state Board of Pharmacy, or other regulatory inspections related to commercial distribution, licensing, packaging, or product traceability.

• Preferred: Experience with small-molecule oral solid dosage products.

• Preferred: Familiarity with state pharmaceutical licensing, NABP programs, EPCIS, or artwork-management platforms.

🏝️ Benefits

• 100% paid health benefits, including Medical, Dental, and Vision coverage for you and your dependents.

• 401(k) program with company match and vesting after the first month following your start date.

• Flexible time off policy.

• Generous parental leave.

• Enjoyable fringe perks.

• Additional compensation, such as bonuses and equity, may be available.