Manager, Manufacturing Quality Assurance, Raw

**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**:
As a QA Manufacturing representative, you will be a pivotal part of our Quality Assurance team, focusing on critical raw materials. This role involves ensuring compliance with regulatory standards, collaborating with cross-functional teams, and driving quality performance improvements. You will be responsible for reviewing and approving documentation, managing supplier manufacturing investigations, and supporting technology transfer activities. Your expertise will help maintain the highest quality standards and contribute to the continuous improvement of our manufacturing processes.

**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.
- 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.

**Reports to**:Director, Quality Assurance, Raw Materials

**Location**:San Carlos, CA

**Compensation**:
The compensation package will be competitive and includes an equity component.

Vaxcyte Switzerland GmbH

Rottenstrasse 5

3930 Visp, Valais

Switzerland

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.