Sabin Vaccine Institute logo
Sabin Vaccine Institute

The Sabin Vaccine Institute is a global health nonprofit self-described as a leading advocate for broadening vaccine access and uptake, advancing research and d

Director, Quality Systems – Research & Development

Location

United States

Posted

1 day ago

Salary

$217K - $240K / year

Seniority

Lead

Bachelor Degree12 yrs expEnglish

Job Description

Director, Quality Systems – Research & Development

Sabin Vaccine Institute

• 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.

Job Requirements

  • 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.

Benefits

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

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