Manager, Quality Assurance, External Manufacturing

<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 Manager, Quality Assurance, External Manufacturing is responsible for overseeing quality activities at contract manufacturing organizations (CMOs), ensuring compliance with cGMP standards, and driving performance through KPIs and continuous improvement initiatives. This role leads batch disposition, reviews critical GMP documentation, supports PPQ activities, and collaborates cross-functionally to resolve complex manufacturing and quality issues. The position requires strong expertise in pharmaceutical quality systems, regulatory requirements, and risk management, along with leadership, problem-solving, and communication skills to support both clinical and commercial operations.</p> <h3>Essential Functions:</h3> <ul> <li>Provide Quality Assurance oversight of Contract Manufacturing Organizations (CMOs).</li> <li>Develop and report metrics and key performance indicators (KPIs) to evaluate CMO performance.</li> <li>Represent Quality Assurance at internal cross-functional meetings and Joint Project Team meetings.</li> <li>Lead polysaccharide batch dispositio