Manager, Quality Assurance, Compliance

<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>Vaxcyte is seeking a Manager, Quality Assurance, Compliance who is responsible for providing day-to-day operational oversight<strong> </strong>governance and strategic oversight of key Quality System processes, with a primary focus on leading Change Control governance and deviation/investigation oversight<strong> </strong>review board leadership.<strong> </strong>This role insures consistent, risk-based decision making, inspection readiness, and cross-functional accountability across quality systems. The Manager acts as an operational backbone<strong> </strong>a governance leader for cross-functional quality processes, proactively identifying systemic risks, ensuring procedural compliance, driving performance through KPIs, and presenting quality system health and trends through Management Review.</p> <h3>Essential Functions:</h3> <ul> <li><strong>Change Control Governance & Board Leadership</strong> <ul> <li>Lead and coordinate the Change Control Review Board (CCRB), including agenda development, facilitation, quorum confirmation, and documentation of decisions.</li> <li>Perform pre-CCRB QA review of Change Requests to ensure completeness, clarity, and appropriate risk classification prior to board review.</li> <li>Verify alignment of Change Requests with applicable SOPs, including confirmation of CCRB-required versus discretionary changes.</li> <li>Provide QA authority on change classification, risk assessment, impact evaluation, and implementation strategy.</li> <li>Own CCRB performance metrics, including cycle time, risk categorization trends, backlog, and recurring impact areas. Present trends and risk signals to senior leadership and during Management Review.</li> </ul> </li> <li><strong>Deviation and Investigation Governance</strong> <ul> <li>Lead or co-lead Deviation Review Boards to ensure consistent, risk-based decision making.</li> <li>Ensure appropriate classification (minor, major, critical) and scientifically sound investigations.</li> <li>Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).</li> <li>Ensure linkage between deviations, CAPA, and change controls to prevent recurrence and address systemic risk.</li> </ul> </li> <li><strong>Quality Metrics and Management Review</strong> <ul> <li>Own development, maintenance, and reporting of Quality System KPIs related to Change Control, Deviations, Investigations, and CAPA.</li> <li>Perform routine trend analysis and signal detection to identify emerging compliance risks.</li> <li>Prepare and present Quality System performance data during Management Review.</li> </ul> </li> <li><strong>Inspection Readiness and Regulatory Support</strong> <ul> <li>Serve as Subject Matter Expert (SME) for Change Control and Deviation processes during regulatory inspections and audits.</li> <li>Support preparation of audit responses and ensure timely and compliant closure of observations.</li> <li>Maintain processes in a continuous state of inspection readiness.</li> </ul> </li> </ul> <h3>Requirements: </h3> <ul> <li>Bachelor’s degree in Life Sciences or a related field.</li> <li>5+ years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industry. Other combinations of education and/or experience may be considered.</li> <li>Experience leading cross-functional governance boards strongly preferred.</li> <li>Strong understanding of ICH Q10, risk management principles, and inspection expectations.</li> <li>Experience with electronic Quality Management Systems (eQMS) strongly preferred.</li> <li>In-depth knowledge of cGMP regulations.</li> <li>Excellent organizational skills, attention to detail, and ability to manage multiple priorities.</li> <li>Strong interpersonal and communication skills to work effectively across functions and with external partners.</li> </ul> <div><strong>Reports to: </strong>Associate Director, QA, Compliance</div> <div> </div> <div><strong>Location: </strong>San Carlos, CA; Hybrid</div> <div> </div> <div><strong>Compensation:</strong></div> <div>The compensation package will be competitive and includes comprehensive benefits and an equity component.</div> <div> </div> <div><strong>Salary Range: </strong>$151,000 – $176,000 (SF Bay Area). Salary ranges for non-California locations may vary.</div><div class="content-conclusion"><p><em>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.</em></p> <p> </p></div>