Director, Quality Systems – Research & Development

Sabin Vaccine Institute

Strategic quality leader managing Quality Management System advancements for vaccine development and commercialization. Collaborating across functions and ensuring regulatory compliance for Sabin’s initiatives.

Posted 6/30/2026full-timeRemote • 🇺🇸 United StatesLead💰 $217,000 - $240,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Systems DevelopmentDocument ControlCorrective and Preventative Actions (CAPA)Risk ManagementInspection ReadinessProcess ValidationTechnology TransferQuality Metrics ProgramsBiologics DevelopmentAnalytical Method Lifecycle Management

Soft Skills

LeadershipTeam DevelopmentStakeholder InfluenceOrganizational TransformationContinuous Improvement