Senior Manager, Quality Assurance - Conjugation & Drug Substance

<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 Conjugation and Drug Substance manufacturing 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 Functions:</h3> <ul> <li>QA Manufacturing representative for Conjugation / Drug Substance at Vaxcyte.</li> <li>Represent QA at internal and external cross functional team meetings.</li> <li>Review and approve internal and external documentation for compliance such as deviations, risk assessments, change controls, and CAPAs.</li> <li>Responsible for thorough QA review of CMO executed batch records in compliance with current regulatory guidance and industry practices and follow up on CMO responses.</li> <li>Review disposition package of Conjugation/Drug Substance per global applicable regulatory requirements and provide to management for release.</li> <li>Develop, implement and maintain procedures and policies as they apply to Conjugation/Drug Substance manufacturing for the Vaxcyte quality organization as needed.</li> <li>Drive resolution of quality performance issues with contract manufacturers and proactively escalate issues to Vaxcyte management.</li> <li>Provide guidance on supplier manufacturing investigations.</li> <li>Support technology transfer activities and review of technology transfer documents.</li> <li>Participate in process improvement projects.</li> <li>Interact with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence.</li> </ul> <h3>Requirements: </h3> <ul> <li>BS or BA with at le ... (truncated, view full listing at source)