Manager, Manufacturing Quality Assurance, Raw Materials

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  RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

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  AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

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  LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

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  MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Essential Functions:

• QA Manufacturing representative for critical raw materials 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.
• Provide thorough QA review of CMO executed batch records in compliance with current regulatory guidance and industry practices and follow up on CMO responses.
• Prepare disposition package of critical raw materials per global applicable regulatory requirements and provide to management for release.
• Review and approve Raw Materials shipment authorization forms.
• Develop, implement and maintain procedures and policies as they apply to critical raw materials and the Vaxcyte quality organization as needed.
• Drive resolution of quality performance issues with contract manufacturers and proactively escalate issues to 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 at least 8 years Quality Assurance experience.
• 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.