Director, Supply and Distribution Quality

🕒 Setembro 21

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $180.000 - $215.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 4%

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Definium Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Definium Therapeutics é uma empresa de biotecnologia em estágio clínico, desenvolvendo terapias de precisão derivadas de psicodélicos para distúrbios psiquiátricos e neurodesenvolvimentais. A empresa foca em formulações farmacêuticas otimizadas de lisergida (LSD) e um R-enantiômero de MDMA para tratar condições como transtorno depressivo maior, transtorno de ansiedade generalizada e sintomas centrais do transtorno do espectro autista, avançando candidatos através de ensaios pré-clínicos e clínicos com uma abordagem científica e baseada em evidências.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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