Senior Manager, Quality Assurance

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3> <div>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. </div> <div> </div> <div><strong>WHAT</strong> we do is every bit as important as <strong>HOW</strong> we do it! Our work together is guided by four enduring core values:</div> <div> </div> <div>*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.</div> <div> </div> <div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div> <div> </div> <div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div> <div> </div> <div>*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3><strong>Summary:</strong></h3> <p>The Senior Manager, Quality Assurance will serve as the Quality Assurance lead for Drug Substance intermediates and custom raw material activities, ensuring all operations performed at Contract Manufacturing Organizations (CMOs) meet Vaxcyte’s quality standards and global regulatory requirements. This role acts as the primary QA representative across internal and external cross-functional teams, providing oversight of deviations, investigations, risk assessments, change controls, and CAPAs. The Senior Manager will conduct detailed reviews of batch records, disposition packages, and technology transfer documents, driving timely issue resolution with CMOs and escalating risks as needed.</p> <p>In addition, this position will develop and enhance QA procedures, support continuous improvement initiatives, and contribute subject-matter expertise on biologics manufacturing and Quality Systems. The ideal candidate brings deep GMP knowledge, strong communication and collaboration skills, and the ability to thrive in a fast-paced, matrixed environment while managing multiple priorities.</p> <h3>Essential Funct