This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Supply and Distribution Quality based in United States.
As a Director, Supply and Distribution Quality, you will lead Quality oversight across an outsourced commercial pharmaceutical supply network.
Your scope will cover packaging, labeling, storage, transportation, distribution, serialization, returns, and product traceability activities.
You will provide strategic and operational Quality leadership to external manufacturing, packaging, logistics, distribution, and technology partners.
The role is critical to commercial launch readiness and the continued availability of compliant, secure, and reliable product supply.
You will establish risk-based governance while managing significant quality, compliance, and product-security risks across the external network.
Working cross-functionally, you will influence senior stakeholders, support regulatory inspection readiness, and drive continuous improvement across Quality systems and partner performance.
This is a high-impact leadership opportunity requiring deep pharmaceutical GMP expertise and approximately 15% travel.
Accountabilities:
- Provide Quality leadership and ownership for commercial packaging and labeling activities performed by contract manufacturing and packaging organizations 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.
- Approve packaging artwork and labeling components from a GMP perspective, ensuring version control, implementation accuracy, reconciliation, and appropriate change control while coordinating with Regulatory Affairs on 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.
- Review final batch and packaging records and make final batch disposition and release-to-market decisions.
- Lead Quality oversight for storage, transportation, returns, destruction, distribution, and reverse-logistics activities across the outsourced commercial network.
- Drive Quality readiness for commercial launch, including 3PL onboarding, distribution-lane qualification, returns processing, traceability-data exchange, mock recalls, and initial market supply.
- Establish risk-based oversight of 3PLs, distributors, carriers, depots, storage facilities, transportation lanes, equipment, and supporting systems through qualification, validation, performance monitoring, periodic review, and inspection readiness.
- Oversee logistics-related quality events, including temperature excursions, shipment damage, loss, theft, diversion, security incidents, and delivery exceptions.
- Coordinate investigations, product-impact assessments, escalation, and disposition activities with relevant functional owners.
- Serve as the Supply Quality lead for recalls, mock recalls, distribution holds, market actions, and returns, including resulting product dispositions.
- Lead the DSCSA Quality compliance program and incorporate applicable pharmaceutical supply-chain requirements 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 product-traceability platforms in partnership with Supply Chain and Trade & Distribution teams.
- Lead or oversee investigations involving suspect or illegitimate products, including quarantine, verification, trading-partner communication, disposition, corrective action, and required regulatory notifications.
- Monitor evolving regulatory requirements and industry standards and translate applicable changes into procedures, training, partner expectations, and readiness plans.
- Own and continuously improve procedures covering packaging quality, distribution quality, product traceability, returns, suspect products, and related quality events.
- Serve as the Quality relationship owner for commercial supply partners while operating within established supplier qualification, audit, approved-supplier, and quality-agreement processes.
- Represent Quality in recurring external partner meetings and lead the Quality component of business review meetings.
- Lead inspection readiness and provide Quality representation or partner-site support for FDA, state licensing authorities, Boards of Pharmacy, and other applicable inspections.
- Ensure significant commercial supply quality events are promptly escalated, investigated, assessed for product and compliance impact, and addressed through effective CAPAs.
- 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.
- Establish functional strategy, priorities, performance indicators, and resource plans aligned with commercial launch and ongoing supply objectives.
- Influence internal stakeholders and external partners through clear governance, risk-based decision-making, effective escalation, and strong cross-functional leadership.
Requirements
- Bachelor’s degree in life sciences, engineering, pharmacy, supply chain, or a related discipline.
- At least 10 years of progressive commercial pharmaceutical or biotechnology GMP Quality Assurance experience.
- Demonstrated leadership of commercial supply, external partner, and cross-functional Quality programs.
- Proven 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, CAPAs, change control, complaints, and regulatory inspection readiness.
- Experience with serialization, traceability-data exchange, suspect-product processes, or related product-security controls.
- Experience making risk-based Quality decisions and influencing senior leaders and external partners without direct operational authority.
- Experience supporting the distribution of controlled substances.
- Strong cross-functional leadership, communication, stakeholder-management, and problem-solving skills.
- Ability to establish effective governance and drive accountability across internal teams and external partners.
- Ability to travel approximately 15%, with periodic increases during launches, significant investigations, partner qualifications, or regulatory inspections.
- Experience with commercial product launches, 3PL implementation, distribution-lane qualification, mock recalls, and initial market supply is preferred.
- Experience with serialization or product-traceability platforms is preferred.
- Experience supporting FDA, state Board of Pharmacy, or other regulatory inspections involving commercial distribution, licensing, packaging, or product traceability is preferred.
- Experience with small-molecule oral solid dosage products is preferred.
- Familiarity with state pharmaceutical licensing, NABP programs, EPCIS, or artwork-management platforms is preferred.
Benefits
- Starting base salary range of $180,000–$215,000 USD.
- Additional compensation opportunities, including bonus and equity.
- 100% company-paid medical, dental, and vision coverage for employees and dependents.
- 401(k) program with company match.
- 401(k) contributions vest after the first month following the employee’s start date.
- Flexible time off.
- Generous parental leave.
- Additional fringe benefits and employee perks.
- Opportunity to play a critical role in commercial launch readiness and ongoing pharmaceutical supply.
- High-impact leadership scope across packaging, distribution, logistics, serialization, and product traceability.
- Cross-functional exposure to Quality, Supply Chain, Pharmaceutical Development, Regulatory Affairs, Trade & Distribution, Information Technology, and external partners.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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