Summary:

The Senior Manager, Quality Assurance will serve as the Quality Assurance lead for Drug Substance intermediates and custom raw material activities, ensuring all operations performed at Contract Manufacturing Organizations (CMOs) meet Vaxcyte’s quality standards and global regulatory requirements. This role acts as the primary QA representative across internal and external cross-functional teams, providing oversight of deviations, investigations, risk assessments, change controls, and CAPAs. The Senior Manager will conduct detailed reviews of batch records, disposition packages, and technology transfer documents, driving timely issue resolution with CMOs and escalating risks as needed.

In addition, this position will develop and enhance QA procedures, support continuous improvement initiatives, and contribute subject-matter expertise on biologics manufacturing and Quality Systems. The ideal candidate brings deep GMP knowledge, strong communication and collaboration skills, and the ability to thrive in a fast-paced, matrixed environment while managing multiple priorities.

Essential Functions:

• QA Manufacturing representative for Drug Substance intermediates and custom raw material at Vaxcyte.
• Represent QA at internal and external cross functional team meetings.
• Review and approve internal and external documentation for compliance such as deviations, risk assessments, change controls, and CAPAs.
• Responsible for thorough QA review of CMO executed batch records in compliance with current regulatory guidance and industry practices and follow up on CMO responses.
• Review disposition package of Drug Substance intermediates and custom raw materials per global applicable regulatory requirements and provide to management for release.
• Develop, implement and maintain procedures and policies as they apply to Drug Substance intermediates and custom raw material manufacturing for the Vaxcyte quality organization as needed.
• Drive resolution of quality performance issues with contract manufacturers and proactively escalate issues to Vaxcyte management.
• Provide guidance on supplier manufacturing investigations.
• Support technology transfer activities and review of technology transfer documents.
• Participate in process improvement projects.
• Interact with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence.

Requirements: 

• BS or BA with a minimum of 8 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.
• Knowledge in both clinical and commercial product desired.
• 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.
• Required experience with good documentation practices, technical writing, and cGMP standards.