Director, Supply and Distribution Quality

Definium Therapeutics

. Provide Quality ownership and leadership for commercial packaging and labeling activities performed by CMOs and CPOs from launch readiness through post-approval lifecycle management .

Posted 9/21/2026full-timeRemote • United StatesLead💰 $180,000 - $215,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in Quality Assurance within the pharmaceutical and biotechnology sectors, focusing on GMP compliance, serialization, and traceability. Proven ability to lead quality oversight for commercial packaging and labeling, manage external supply partnerships, and ensure regulatory compliance during inspections.

Highest-signal resume keywords

GMP Quality AssuranceSerialization and TraceabilityCommercial Distribution Quality SystemsSupplier Oversight and AuditsRisk-Based Quality Decision-Making

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality Management SystemCAPAChange ControlArtwork ImplementationProduct TraceabilityQuality AgreementsInspection ReadinessControlled Substances DistributionMock Recalls3PL Implementation

Soft Skills

LeadershipInfluencing StakeholdersCommunication

Tools & Technologies

Serialization PlatformsTraceability PlatformsArtwork-Management Platforms

Industry Keywords

CGMPGood Distribution PracticeDSCSAPharmaceutical LicensingNABP ProgramsEPCIS

About the role

Key responsibilities & impact

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 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 for GMP compliance, version control, implementation accuracy, reconciliation, and change control
Oversee outsourced packaging and labeling readiness and lifecycle management, including artwork implementation, component qualification, line trials, process validation, serialization, reconciliation, and change control
Review final batch and packaging records and make final batch dispositions/releases to market
Lead Quality oversight of storage, transportation, returns, destruction, and distribution, including reverse logistics
Lead commercial launch readiness 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
Oversee logistics-related quality events including temperature excursions, shipment damage, loss, theft, diversion, security events, and delivery exceptions
Serve as Supply Quality lead for recalls, mock recalls, distribution holds, market actions, and returns
Lead the company’s DSCSA Quality compliance program and incorporate applicable requirements into the Quality Management System
Establish 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 oversee suspect and illegitimate product investigations, including quarantine, verification, communication, disposition, corrective action, and regulatory notification
Monitor regulatory requirements and industry standards and translate changes into procedures, training, partner expectations, and readiness plans
Own and continuously improve procedures governing packaging quality, distribution quality, product traceability, returns, suspect product, and related quality events
Manage Quality relationships with commercial supply partners through supplier qualification, audit, approved-supplier, and quality-agreement processes
Represent Quality in external partner meetings and lead the quality portion of business review meetings
Lead inspection readiness and provide Quality representation or partner-site support for FDA, state licensing authority, Board of Pharmacy, and other inspections
Ensure significant quality events are escalated, investigated, assessed for product and compliance impact, and addressed through CAPA
Track, trend, and report quality and compliance indicators to senior leadership and Management Review
Establish functional strategy, priorities, performance indicators, and resource plans aligned with launch and ongoing commercial supply objectives
Influence internal stakeholders and external partners through governance, risk-based decision-making, and escalation

Requirements

What you’ll need

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: 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 involving 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

Comp & perks

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
Fun fringe perks
Additional compensation, including bonus and equity may be available