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, periodontitis 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:Vaxcyte has an exciting opportunity for a Sr. Manager, Manufacturing QA Raw Materials to join their Quality team.
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 Master Batch Records, 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 for management approval to enable timely 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 Manufacturing investigations.
- Good Judgement and Decision-Making: The role necessitates making critical decisions that impact Raw Material quality and compliance, which have direct impacts on company strategic goals and milestones.
- 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 9 years relevant industry experience.
- In-depth knowledge of GMPs, FDA 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.
- Strong overall knowledge of manufacturing processes and Quality Systems.
Reports to: Director, Quality Assurance, Raw Materials
Location: San Carlos, CA/ Hybrid
Compensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $176,000 - $195,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
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.