Vice President, Quality

🕒 Outubro 9

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $250.000 - $315.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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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

• Develop and execute a roadmap to mature the phase-appropriate QMS across GMP, GCP, GVP, and GLP • Advise executive leadership on quality, compliance, inspection readiness, and risk management • Embed quality culture across functions, partners, and development programs • Own quality governance, metrics, escalation pathways, management review, and quality risk management frameworks • Provide senior leadership for GMP quality activities supporting vaccine development, technology transfer, process validation, PPQ, commercial readiness, and lifecycle management • Oversee GCP quality systems, clinical-development audits, inspection readiness, vendor oversight, and quality risk management • Oversee GVP quality activities, including adverse-event reporting, signal management, aggregate safety reporting, and regulatory compliance • Oversee GLP-related quality activities supporting nonclinical studies • Establish and approve quality agreements and oversee risk-based qualification, auditing, monitoring, and requalification of GxP partners • Ensure partner responsibilities, escalation and reporting requirements, audit and data-access rights, change and deviation notification, CAPA management, inspection support, and remediation • Provide quality oversight for validated GxP systems, document and data governance, records retention, data integrity, and remote-inspection capabilities • Partner with IT on cybersecurity and business-continuity requirements for GxP systems • Lead inspection readiness and serve as sponsor quality lead for FDA BIMO, PAIs, surveillance inspections, and other health authority inspections • Direct critical investigations involving serious breaches, safety or data-integrity concerns, manufacturing deviations, or systemic quality failures • Ensure GxP documentation and quality systems are complete, controlled, inspection-ready, and aligned with FDA, EMA, ICH, WHO, and other expectations • Identify and escalate quality risks and drive mitigation • Recruit, develop, mentor, and retain Quality professionals • Contribute quality content to INDs, BLAs, MAAs, health-authority responses, and related regulatory submissions • Provide Quality leadership for funding proposals and due-diligence activities

🎯 Requisitos

• Bachelor’s degree in a relevant scientific, engineering, quality, or related field • At least 16 years of progressively responsible quality experience in biologics development and manufacturing • Experience with vaccines, viral vectors, or similarly complex biologics strongly preferred • Proven people-leadership experience and success driving organizational change, preferably in a small biotechnology and/or virtual organization • Experience serving on an R&D or executive leadership team preferred • Demonstrated success developing or substantially transforming a QMS in preparation for late-stage development and licensure • Direct experience supporting late-stage clinical development, process validation, PPQ, PAI readiness, and BLA/MAA submissions • Experience leading health authority inspections and interacting with FDA and other global regulatory agencies • Expert knowledge of GMP, GCP, GLP, and GVP requirements; relevant ICH guidelines, including ICH E6(R3), E8, E9, Q9, and Q10; and applicable FDA, EMA, MHRA, WHO, and other global regulatory expectations • Demonstrated experience establishing sponsor oversight and quality governance across outsourced development and manufacturing networks, including CDMOs, CROs, and contract laboratories • Broad understanding of interdependencies among nonclinical development, translational science, Phase 3 clinical operations, pharmacovigilance, biostatistics and data management, CMC, regulatory strategy, and quality • Ability to identify and mitigate cross-functional risks to licensure • Ability to lead collaboratively across technical functions, external partners, geographic regions, and matrixed teams • Strong judgment, problem-solving, and interpersonal skills • Experience supporting U.S. government-funded projects preferred • Must demonstrate interest in furthering Sabin’s mission • Subject to a criminal background investigation • Three professional references required • Verification of education/degrees • Must be authorized to work in the United States without employer sponsorship • Not eligible for visa sponsorship

🏖️ Benefícios

• 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