Definium Therapeutics - Director, Supply and Distribution Quality
Requirements
• 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. • 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. • The starting base pay range for this position is $180,000.00-215,000.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location. • Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including: • 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!
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
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