Executive Director, Quality Assurance, External Manufacturing

Job title: Executive Director, Quality Assurance, External Manufacturing

About the Role

The Executive Director, Quality Assurance, External Manufacturing leads the External Manufacturing Quality function across Vaxcyte's global CDMOs and external partners. In a highly outsourced model, this role ensures externally executed GMP activities meet global regulatory requirements and Vaxcyte quality standards, supporting product quality, supply continuity, and regulatory readiness. The leader drives a proactive, risk-based quality approach and implements scalable systems, governance, and partnerships to enable operational excellence across the external network, enabling clinical development, BLA readiness, and commercial supply. The Executive Director owns external quality performance and decision-making, escalating critical risks and aligning with VP-level strategy, with strong cross-functional influence in a matrixed environment.

What You'll Do

• Own quality performance across the external network, ensuring compliance, supply continuity, and effective management of quality risk, escalating critical risks to VP-level as appropriate.
• Provide end-to-end QA leadership for externally executed GxP activities, including manufacturing and release of drug substance, drug product, components, and critical raw materials.
• Serve as the senior QA leader for external operations, representing Quality in cross-functional and executive forums, influencing decisions across Technical Operations, CMC, Regulatory, and Supply Chain.
• Establish and maintain strategic partnerships with external partners, driving accountability, performance management, and continuous improvement.
• Lead quality governance across the external network, including KPIs, escalation pathways, and risk-based oversight models focused on critical processes and high-risk partners.
• Oversee and drive resolution of complex, cross-organizational quality issues, ensuring robust investigations, root cause analysis, and sustainable CAPAs.
• Provide oversight and decision authority for batch disposition and product release, ensuring timely, compliant supply of clinical and commercial materials.
• Drive inspection readiness across the external network, including PAI and global health authority inspections, and serve as a key QA representative during inspections.
• Provide strategic QA leadership for technology transfer, process validation, and lifecycle management across external sites.
• Build, lead, and develop a high-performing External Quality organization, including talent development, succession planning, and organizational scalability.
• Champion a strong quality culture across internal teams and external partners, reinforcing accountability, transparency, and continuous improvement.

What We're Looking For

• BS/BA required, with a minimum of 16 years of progressive experience in Quality Assurance within biopharmaceuticals, including significant leadership in external manufacturing and CDMO oversight; vaccines experience desirable.
• Deep expertise in GMP regulations, FDA and global regulatory expectations, and ICH guidelines.
• Extensive experience operating within a highly outsourced/CDMO-based manufacturing model.
• Proven track record of leading complex external quality networks, driving performance and outcomes without direct authority.
• Strong experience supporting technology transfer, process validation, and lifecycle management across multiple external sites.
• Demonstrated success in inspection readiness and regulatory inspections, including pre-approval inspections (PAIs).
• Experience establishing governance frameworks and performance metrics for external partners.
• Strong background in risk management and quality systems, with the ability to apply risk-based decision-making in a GxP environment.
• Proven ability to influence at the executive level, driving alignment across cross-functional teams and external partners.
• Demonstrated experience building, leading, and scaling high-performing teams in a complex, fast-paced environment.
• Strong business acumen, with the ability to balance quality, compliance, and supply continuity to support clinical and commercial objectives.

Nice to Have

• Vaccines experience desirable.

Compensation & Benefits You are trained on data up to October 2023.