Vice President, Quality

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $250k - $315k / year

⏰ Full Time

🔴 Lead

👔 Vice President

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Sabin Vaccine Institute

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 $35M Grant on 2023-01

Healthcare • Consulting • Food & Beverage

Sabin Vaccine Institute is dedicated to improving global health by ensuring access to life-saving vaccines. The institute focuses on research and development of new vaccines for some of the world’s most pressing diseases, including cholera, HPV, malaria, Marburg, and Ebola. Through innovative programs and partnerships, Sabin aims to enhance immunization capacities and vaccine acceptance within communities, ultimately striving to make vaccination accessible to all, especially vulnerable populations.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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