Director, Quality Systems, Research & Development (R&D)

Reports to: Senior Director, Quality (R&D)

Location: Remote work, US Only 

Why Sabin: 

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary:

The Director, Quality Systems, R&D, is a strategic quality leader responsible for evolving Sabin's Quality Management System (QMS) as the organization advances from clinical-stage development to late-stage development, licensure readiness, and future commercialization. This role will be instrumental in supporting Sabin's first Biological License Application (BLA) and ensuring alignment with 21 Code of Federal Regulation (CFR), International Council for Harmonization (ICH) Q10, ICH Q9, and global regulatory expectations. Reporting to senior quality leadership, the Director provides oversight of the electronic Quality Management Systems (eQMS), inspection readiness, supplier quality, quality risk management, data integrity, management review, and quality culture initiatives.

Responsibilities: 

• 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.

• 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.

Other: 

• Subject to a criminal background investigation
• Request for three professional references
• Verification of education/degrees 

Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $217,000 - $240,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.

Sabin provides a comprehensive benefits package for eligible, featuring medical, dental, and vision coverage as well as flexible spending accounts. Eligible employees enjoy flexible vacation leave, sick leave, and both short-term and long-term disability options. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.