Senior Manager, Quality Assurance, Raw Materials presso Vaxcyte
Vaxcyte · San Carlos, Stati Uniti d'America · Hybrid
- Senior
- Ufficio in San Carlos
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Summary:
The Sr. Manager, QA, Raw Materials ensures quality oversight and compliance across manufacturing activities. This role serves as the QA liaison for internal teams and external partners, reviewing and approving key documentation and materials, driving resolution of quality issues, and ensuring adherence to regulatory standards. The position also supports process improvements, policy development, and effective collaboration to uphold Vaxcyte’s commitment to quality excellence.
Essential Functions:
- Serve as QA Manufacturing representative for Critical Raw Materials.
- Represent Quality Assurance at internal and external cross functional team meetings, providing quality input and oversight.
- Review and approve internal and external documentation for compliance including Master Batch Records, deviations, risk assessments, change controls, and CAPAs.
- Perform QA review of CMO executed batch records in compliance with current regulatory guidance and industry practices and follow up on CMO responses as needed.
- Prepare disposition package of Critical Raw Materials to enable timely release.
- Review and approve Raw Materials shipment authorization forms in accordance with established procedures.
- Develop, implement, and maintain procedures and policies related to critical Raw Materials and the Vaxcyte quality organization, ensuring alignment with quality and regulatory standards.
- Identify compliance gaps and drive resolution of quality and performance issues with contract manufacturers and proactively escalate issues to management, when appropriate.
- Provide guidance on Manufacturing investigations and ensure implementation of effective Corrective and Preventative Actions.
- Exercise sound judgement and decision-making.
- Facilitate process improvement projects to enhance efficiency, compliance, and quality performance.
- Collaborate with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence.
Requirements:
- BS or BA with a minimum 8 years of experience. Other combinations of education and/or experience may be considered.
- In-depth knowledge of GMPs, FDA regulations and ICH guidelines.
- Strong attention to detail.
- Knowledge in both clinical and commercial product.
- 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.
- Strong overall knowledge of manufacturing processes and Quality Systems.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
