Director, Quality Assurance – Vendor Management

Summary:

The Director, Quality Assurance – Vendor Management is responsible for executing the global vendor quality strategy to ensure compliance, scalability, and inspection readiness across Vaxcyte’s GxP supplier network. This role provides leadership and oversight of vendor qualification, audit, supplier notifications, and performance management programs, ensuring alignment with corporate objectives and regulatory expectations.

The Director will serve as a key quality leader, influencing cross-functional stakeholders and external partners, while driving continuous improvement, risk-based decision-making, and operational excellence across the vendor ecosystem.

Essential Functions:

• Strategic Leadership & Program Ownership
  • Own and define the global Vendor Management Quality Program, ensuring scalability to support clinical and commercial operations.
  • Provide end-to-end oversight of vendor qualification, auditing, monitoring, and lifecycle management programs.
  • Establish and drive risk-based frameworks for supplier selection, qualification, and oversight aligned with regulatory expectations.
  • Serve as the QA lead for external partnerships, including CMOs, CROs, and critical service providers.
• Audit & Inspection Readiness
  • Oversee the global supplier audit program including preparation, scheduling, performance and audit closeout.
  • Ensure inspection readiness across the vendor network and support regulatory inspections as a QA subject matter expert.
  • Review and approve audit strategies, reports, and CAPA effectiveness, ensuring timely closure and systemic improvement.
  • Plan, schedule, and conduct supplier audits (on-site and remote) in support of supplier qualification and ongoing oversight programs.
• Quality Systems & Governance
  • Provide strategic direction and oversight for Quality Agreements, working closely with the Associate Director, Quality Agreements, who leads day-to-day management and execution.
  • Establish and monitor vendor performance metrics and quality KPIs, reporting trends and risks to executive leadership.
  • Ensure robust processes for supplier change management, deviations, and CAPAs related to vendor activities.
  • Drive continuous improvement initiatives to enhance vendor quality systems, compliance, and efficiency.
• Cross-Functional Leadership & Influence
  • Act as a strategic partner to Technical Operations, Clinical, Regulatory, and Supply Chain teams.
  • Provide expert guidance on risk management, vendor selection, and mitigation strategies.
  • Influence decision-making at the senior leadership level through data-driven insights and quality risk assessments.
• Team Leadership & Development
  • Build, lead, and develop a high-performing Vendor Management QA team.
  • Foster a culture of quality excellence, accountability, and continuous improvement.
  • Mentor and develop talent, ensuring organizational capability scales with company growth.
• External Engagement
  • Serve as the primary QA contact for key vendors and partners.
  • Represent Quality in executive-level vendor governance meetings.
  • Ensure external partners operate in alignment with Vaxcyte’s quality standards and expectations.

Requirements: 

• BS/BA in a scientific discipline and minimum 12 years of relevant experience in GxP Quality within the biotech/pharmaceutical industry. Other combinations of education and/or experience may be considered.
• Extensive experience in vendor management, supplier quality, and audit programs.
• Deep knowledge of GMPs, FDA regulations, and ICH guidelines.
• Demonstrated expertise in risk management principles and quality systems.
• Experience supporting both clinical and commercial-stage products strongly preferred.
• Proven ability to lead teams and influence cross-functional stakeholders at senior levels.
• Strong track record of inspection readiness and regulatory interactions.
• Excellent communication, leadership, and organizational skills.
• ASQ certification (CQA, CQE) or auditor certification preferred.