Sr. Manager, Quality Assurance at Vaxcyte, Inc.
San Carlos, CA
About the Job
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:
*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.
*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.
*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:
Requirements:
Reports to: Senior Director, Quality Assurance
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $176,000 – $190,000
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:
*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.
*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.
*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 Representative for quality management of analytical activities for Vaxcyte intermediates and/or drug substances.
- Represent QA at internal and external cross functional team meetings.
- Key participant in quality team focused on the oversight of analytical processes and results at CMOs.
- Review and approve internal and external documentation for compliance such as analytical methods and their validation protocols and reports, risk assessments, change controls, deviations and CAPAs as they related to QC for Vaxcyte intermediates.
- Review and approval of specifications and COAs for intermediates.
- Review and approval of all documentation related to reference standards for intermediates.
- Establish, review, and periodically update GMP related internal procedures and policies, as needed.
- Maintain appropriate development-phase compliance for analytical testing of intermediates.
- Support process improvement initiatives.
- Interact with key stakeholder to develop solutions to complex issues.
- Review and assess temperature excursions.
- May participate in compliance audits as required.
- Promote a quality mindset and quality excellence approach to all activities.
Requirements:
- BS or BA with at least 8 years relevant industry experience.
- Demonstrate in-depth knowledge of GMPs, FDA regulations and ICH guidelines.
- Experience in analytical method validation and basic laboratory methodology is desired.
- Knowledge in both clinical and commercial products desired.
- Demonstrate excellent verbal, written, and interpersonal communication skills, collaborative approach essential.
- Demonstrate experience leading and contributing through influence and working in cross functional teams.
- Experience working with Contract Manufacturing Organizations.
- Strong sense of ownership for areas of responsibilities.
Reports to: Senior Director, Quality Assurance
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $176,000 – $190,000
