Vaxcyte
Senior Manager, Quality Assurance, Raw Materials
Vaxcyte, San Carlos, California, United States, 94071
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT
we do is every bit as important as
HOW
we do it! Our work together is guided by four enduring core values:
*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.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
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.
Reports to:
Director, Quality Assurance Raw Materials
Location:
San Carlos, CA; Open to remote
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range:
$164,000 - $191,000 (SF Bay Area). Salary ranges for non-California locations may vary.
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.
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT
we do is every bit as important as
HOW
we do it! Our work together is guided by four enduring core values:
*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.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
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.
Reports to:
Director, Quality Assurance Raw Materials
Location:
San Carlos, CA; Open to remote
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range:
$164,000 - $191,000 (SF Bay Area). Salary ranges for non-California locations may vary.
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.