Overview In this role you lead the External Manufacturing Quality function for Vaxcyte's outsourced model, ensuring GMP compliance and readiness across CDMOs and external partners. You drive a proactive, risk-based QA strategy that supports clinical development, regulatory submissions, and commercial supply. You will influence cross-functional leadership and manage partnerships to sustain supply quality and regulatory readiness. This is a chance to shape quality governance and elevate external operations at scale.
Compensation / Benefits- comprehensive benefits
- equity component
- hybrid work arrangement
- competitive compensation
- location: SF Bay Area
- opportunity for relocation not available
Responsibilities- Own external QA performance across the external network, ensuring compliance, supply continuity, and risk management with executive escalations as needed
- Provide end-to-end QA leadership for externally executed GxP activities including manufacturing and release of drug substance/product
- Serve as senior QA leader for external operations, influencing decisions with Technical Operations, CMC, Regulatory, and Supply Chain
- Establish strategic partnerships with external partners, driving accountability, performance management, and continuous improvement
- Lead quality governance across the external network with KPIs, escalation pathways, and risk-based oversight
- Oversee resolution of complex cross-organizational quality issues with robust investigations and CAPAs
- Provide oversight for batch disposition and product release to ensure timely, compliant supply
- Drive inspection readiness across the external network, including PAIs and governmental inspections
- Provide strategic QA leadership for technology transfer, process validation, and lifecycle management at external sites
- Build and develop a high-performing External Quality organization with succession planning and scalability
- Champion a strong quality culture across internal teams and external partners
Key requirements- BS/BA with 16+ years in Quality Assurance in biopharmaceuticals
- Significant leadership in external manufacturing and CDMO oversight; vaccines experience desirable
- Deep GMP, FDA/global regulatory expectations, and ICH knowledge
- Extensive experience in outsourced manufacturing models and external quality networks
- Proven ability to influence executive stakeholders without direct authority
- Experience with technology transfer, process validation, and lifecycle management across multiple sites
- Proven track record in inspection readiness and regulatory inspections (PAIs)
- Governance and performance metrics development for external partners
- Risk management and quality systems expertise in GxP environments
- Strong leadership, cross-functional collaboration, and organizational development
- Business acumen to balance quality, compliance, and supply continuity
- Cross-functional leadership
- Executive communication
- Influence without authority
- GMP regulatory knowledge (FDA/global)
- ICH guidelines
- GxP quality management
