Manager, Quality Assurance Suppliers and Audits

<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 to support supplier oversight, audit management, and quality systems compliance. This role will lead and perform third-party audits, manage audit responses and CAPAs, and partner with Global Vendor Management and cross-functional teams to support supplier qualification, materials management, and quality agreements. The Manager, Quality Assurance will also contribute to the development and continuous improvement of quality systems and procedures to ensure compliance with cGMPs, regulatory requirements, and internal quality standards.</p> <h3>Essential Functions:</h3> <ul> <li><strong>Audit Program Management </strong> <ul> <li>Performs third-party audits, including notified bodies, vendor and contract manufacturing organization (CMO) audits, ensuring compliance with quality agreements and regulatory expectations.</li> <li>Lead audit observations response and CAPA implementation, ensuring timely closure and effectiveness verification.</li> <li>Collaborate with Global Vendor Management.</li> </ul> </li> <li><strong>Suppliers and Materials Management</strong> <ul> <li>Involved in the process for new supplier’s introduction.</li> <li>Involved in topics related to materials management such as VCNs (Vendor change notification).</li> <li>Involved in the establishment of Quality Agreements and other required regulatory documentation according to cGMP.</li> <li>Represent QA at internal and external cross functional team meetings related to supplier, services and/or materials.</li> </ul> </li> <li><strong>Quality Systems and Compliance</strong> <ul> <li>Review and approve internal and external documentation for compliance such as deviations, risk assessments, change controls, CAPAs related to supplier, services and/or materials.</li> <li>Develop, implement and maintain procedures and policies related to supplier, services and/or materials topics.</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> </li> </ul> <h3>Requirements: </h3> <ul> <li>BS or BA with minimum 5 years of Quality Assurance experience. Other combinations of education and/or experience may be considered.</li> <li>In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines.</li> <li>Strong attention to detail.</li> <li>Significant auditing experience ((ASQ certification (CQA, CQE) o ... (truncated, view full listing at source)