Director, Quality Systems, Research & Development (R&D)
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.
Key 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.
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.
Qualifications
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.