Director, Supply and Distribution Quality

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $180 000 - $215 000 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 3%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Definium Therapeutics

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51 - 200 employés

Fondée en 2019

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Definium Therapeutics est une entreprise de biotechnologie en phase clinique qui développe des thérapeutiques dérivées de substances psychédéliques pour des troubles psychiatriques et neurodéveloppementaux. La société se concentre sur des formulations pharmaceutiquement optimisées de lysergide (LSD) et un énantiomère R de MDMA pour traiter des conditions telles que le trouble dépressif majeur, le trouble anxieux généralisé, et les symptômes principaux du trouble du spectre autistique, faisant progresser les candidats à travers les essais précliniques et cliniques avec une approche dirigée par la science et soutenue par des preuves.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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

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