Manager, Quality Assurance Suppliers and Audits

Vaxcyte is seeking a Manager, Quality Assurance to support supplier oversight, audit management, and quality systems compliance. This role will lead and perform third-party audits, manage audit responses and CAPAs, and partner with Global Vendor Management and cross-functional teams to support supplier qualification, materials management, and quality agreements. The Manager, Quality Assurance will also contribute to the development and continuous improvement of quality systems and procedures to ensure compliance with cGMPs, regulatory requirements, and internal quality standards.

• Audit Program Management
  • Performs third-party audits, including notified bodies, vendor and contract manufacturing organization (CMO) audits, ensuring compliance with quality agreements and regulatory expectations.
  • Lead audit observations response and CAPA implementation, ensuring timely closure and effectiveness verification.
  • Collaborate with Global Vendor Management.
• Suppliers and Materials Management
  • Involved in the process for new supplier’s introduction.
  • Involved in topics related to materials management such as VCNs (Vendor change notification).
  • Involved in the establishment of Quality Agreements and other required regulatory documentation according to cGMP.
  • Represent QA at internal and external cross functional team meetings related to supplier, services and/or materials.
• Quality Systems and Compliance
  • Review and approve internal and external documentation for compliance such as deviations, risk assessments, change controls, CAPAs related to supplier, services and/or materials.
  • Develop, implement and maintain procedures and policies related to supplier, services and/or materials topics.
  • Participate in process improvement projects.
  • Interact with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence.

• BS or BA with minimum 5 years of Quality Assurance experience. Other combinations of education and/or experience may be considered.
• In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines.
• Strong attention to detail.
• Significant auditing experience ((ASQ certification (CQA, CQE) or auditor certification preferred)).
• Materials and suppliers’ management experience.
• Excellent verbal, written, and interpersonal communication skills.
• Experience leading and contributing through influence and working in cross functional teams.
• Ability to work in a fast-paced team environment, and to consistently meet aggressive timelines while prioritizing tasks for multiple projects.
• Ability to adapt to changing priorities.
• Strong overall knowledge of biologics manufacturing processes and Quality Systems. 
• Ability to travel up to 40%.