Senior Director, Quality Control – Program Implementation Lead

🕒 il y a 7 jours

🇺🇸 États-Unis – Télétravail

💵 $216 000 - $243 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 0%

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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Sabin Vaccine Institute

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51 - 200 employés

Fondée en 1993

🏥 Santé

💼 Conseil

🍽️ Alimentation et boissons

💰 €35 000 000 Grant en 2023-01

Healthcare • Consulting • Food & Beverage

L'Institut Sabin pour les Vaccins se consacre à l'amélioration de la santé mondiale en garantissant l'accès à des vaccins vitaux. L'institut se concentre sur la recherche et le développement de nouveaux vaccins pour certaines des maladies les plus urgentes dans le monde, y compris le choléra, le VPH, le paludisme, le Marburg, et l'Ebola. À travers des programmes et des partenariats innovants, Sabin vise à renforcer les capacités de vaccination et l'acceptation des vaccins au sein des communautés, s'efforçant finalement de rendre la vaccination accessible à tous, en particulier aux populations vulnérables.

Description

• Establish Sabin’s first dedicated QC capability • Design and implement a phase-appropriate, current Good Manufacturing Practice (cGMP)-compliant QC framework supporting Phase 2 through Phase 3, PPQ, BLA, and commercialization • Establish the QC operating model, governance, processes, technical standards, and interfaces for drug substance and drug product testing • Collaborate with CMC leadership, CMC Quality, Analytical Sciences, Regulatory, Program Management, external laboratories, and CDMOs • Define QC roles, decision rights, handoffs, documentation requirements, and escalation pathways • Establish and maintain governance and sponsor oversight of laboratories and CDMOs • Support phase-appropriate QC strategies and standards aligned with product development, control strategy, regulatory requirements, and commercialization objectives • Oversee analytical method lifecycle management, specifications, release and stability testing, reference standards, critical reagents, investigations, and inspection readiness • Provide sponsor-level oversight of analytical PPQ readiness and validated in-process, release, characterization, and stability methods • Oversee method transfer, qualification/validation, implementation, lifecycle management, and technical support • Provide technical leadership and risk-based decision-making for analytical and QC issues • Review QC readiness and testing documentation supporting PPQ batches • Lead significant OOS/OOT results, deviations, data integrity concerns, and other QC-related quality risks • Ensure quality agreements define testing, data review and transfer, records retention, audit access, investigations, change notification, reference standards, sample management, stability activities, and escalation responsibilities • Ensure external QC activities are qualified, controlled, monitored, and aligned with GMP requirements, quality agreements, data integrity expectations, and regulatory commitments • Oversee vendor performance, testing activities, QC documentation, investigations, changes, and significant-risk escalation • Establish and maintain QC procedures and quality systems supporting outsourced testing • Support regulatory and US Government submissions, audits, and inspections by ensuring QC data and records are complete, accurate, traceable, reviewed, and consistent • Serve as QC representative on CMC and cross-functional program teams • Integrate QC requirements, dependencies, risks, and deliverables into program planning • Develop and evolve Sabin’s outsourced QC capability, external laboratory/CDMO relationships, technical expertise, systems, governance, and future organizational needs • Establish performance metrics and governance mechanisms to assess external QC network effectiveness, identify risks, and drive continuous improvement • Perform other duties as assigned

🎯 Exigences

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, biology, life sciences, or a related scientific discipline • 14+ years of progressive experience in pharmaceutical/biopharmaceutical QC, analytical sciences, CMC, or a closely related GMP environment • Experience supporting late-stage development and/or commercial manufacturing • Experience supporting USG-funded vaccine or biologics development programs, including BARDA or another federal agency, preferred • Experience with analytical PPQ readiness, vaccine release and stability testing, sponsor oversight of external testing laboratories, and preparing or reviewing QC data for regulatory submissions strongly preferred • Familiarity with quality agreements, contract deliverables, integrated schedules, risk registers, and change-control processes in an outsourced development and manufacturing environment preferred • Demonstrated experience overseeing outsourced QC activities, analytical laboratories, CDMOs, CROs, or other external testing organizations within a GMP environment • Strong knowledge of GMP QC principles, analytical method lifecycle management, method transfer, qualification/validation, specifications, stability and release testing, OOS/OOT investigations, data integrity, and inspection readiness • Demonstrated ability to establish QC governance and oversight within a virtual or matrixed organization and manage technical relationships with external partners • Strong risk-based decision-making, problem-solving, and communication skills • Ability to address unexpected QC issues and communicate technical risks to scientific, quality, regulatory, manufacturing, executive, and external partner audiences • Ability to lead through ambiguity and changing program needs • Experience in both development/start-up and commercial GMP environments strongly preferred • Subject to a criminal background investigation • Request for three professional references • Verification of education/degrees • Must be authorized to work in the United States without employer sponsorship; position is not eligible for visa sponsorship

🏖️ Avantages

• Medical, dental, and vision coverage • Flexible spending accounts • Flexible vacation leave • Sick leave • Short-term disability options • Long-term disability options • 10 federal holidays • End-of-year winter break • Employer matching 401(k) plan

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