Director, Quality Systems – Research & Development

🕒 Julho 7

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Sabin Vaccine Institute

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 1993

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

💰 $35.000.000 Grant em 2023-01

Healthcare • Consulting • Food & Beverage

O Instituto de Vacinas Sabin se dedica a melhorar a saúde global, garantindo o acesso a vacinas que salvam vidas. O instituto foca em pesquisa e desenvolvimento de novas vacinas para algumas das doenças mais urgentes do mundo, incluindo cólera, HPV, malária, Marburg e Ebola. Através de programas e parcerias inovadoras, a Sabin busca melhorar as capacidades de imunização e a aceitação de vacinas dentro das comunidades, esforçando-se para tornar a vacinação acessível a todos, especialmente às populações vulneráveis.

Descrição

• Lead the strategic evolution of Sabin’s QMS to support late-stage clinical development, licensure readiness, and future commercialization. • Oversee and continuously improve eQMS, including document control, training, deviations, Corrective and Preventative Actions (CAPA), change control, risk management, management review, and supplier quality processes. • Develop and maintain quality governance processes, quality metrics, and management review programs that drive compliance, transparency, and continual improvement. • Lead implementation of Quality risk management principles consistent with ICH Q9. • Establish and maintain enterprise inspection readiness programs supporting sponsor audits, regulatory inspections, Bioresearch Monitoring (BIMO) inspections, and Pre-Approval Inspections (PAI). • Provide strategic oversight of supplier quality programs, including qualification, auditing, monitoring, and governance of Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), laboratories, and critical suppliers. • Lead data integrity initiatives and ensure adherence to ALCOA+ principles across GxP systems and processes. • Oversee investigations, deviations, change controls, CAPAs, and effectiveness verification activities. • Partner cross-functionally with Technical Operations, Clinical Development, Regulatory Affairs, Supply Chain, and external partners to ensure phase-appropriate compliance. • Support health authority interactions, inspection responses, and remediation activities, ensuring sustainable corrective and preventive actions. • Promote a culture of quality, accountability, continuous learning, and operational excellence across the organization. • Carry out other responsibilities as needed to support organizational priorities and public health goals.

🎯 Requisitos

• Bachelor’s degree required; advanced degree preferred in Biology, Chemistry, Pharmacy, Engineering, or related scientific discipline. • 12+ years of progressive experience in Quality Assurance and Compliance within biotechnology, vaccines, biologics, or pharmaceutical environment • Demonstrated experience establishing and maintaining Quality Systems supporting clinical development, technology transfer, process validation, inspection readiness, and commercialization preparation. • Extensive experience managing eQMS and quality metrics programs. • Proven experience overseeing CDMOs, CROs, contract laboratories, and other GxP service providers. • Demonstrated experience supporting or leading regulatory inspections and health authority interactions, including FDA inspections, BIMO inspections, and/or PAI. • International experience (EMA, AIFA, MHRA) preferred. • Strong knowledge of FDA regulations, ICH guidelines (including ICH Q10 and ICH Q9), GxP requirements, and biologics/vaccine development. • Strong understanding of sterile manufacturing, analytical method lifecycle management, technology transfer, validation, and cold-chain operations. • Proven track record implementing late-phase quality systems supporting technology transfer, Process Performance Qualification (PPQ) readiness, licensure, commercialization, and BLA/MAA submissions. • Expert knowledge of 21 CFR, ICH Q10, ICH Q9, and FDA guidance applicable to vaccine and biologics development. • Direct people-management experience with demonstrated ability to develop talent and lead organizational transformation. • Demonstrated success building high-performing teams, developing talent, influencing executive stakeholders, and driving organizational transformation. • Occasional travel is required with notice to support organizational alignment and business needs.

🏖️ Benefícios

• medical, dental, and vision coverage • flexible spending accounts • flexible vacation leave • sick leave • short-term and long-term disability options • 10 federal holidays plus an end of the year winter break • employer matching 401(k) plan