Senior Manager, Quality Assurance

<div class="content-intro"><p class="x_MsoNormal"></p> <div class="x_elementToProof"><span data-olk-copy-source="MessageBody">Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics’ flagship commercial product is TRUTAKNATM&nbsp;(atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand<em>&nbsp;(</em>APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit&nbsp;</span><u><a href="https://www.veratx.com">www.veratx.com</a></u>.</div> <div class="x_elementToProof">&nbsp;</div> <div class="x_elementToProof">At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner’s mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney.&nbsp;</div> <p class="x_MsoNormal"></p></div><p><strong>Position Summary:</strong></p> <p>The Senior Manager, Quality Assurance (QA), will report to the Director, QA Drug Substance and is primarily responsible for QA function for Cell Bank and Drug Substance (DS). The position is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Substances meet regulatory requirements and internal Vera standards.</p> <p><strong>Responsibilities: </strong></p> <ul> <li>Support the oversight of the quality and compliance, primarily cell bank and biologics DS manufacturing.</li> <li>Support implementation of strategies and tactics to promote and maintain GxP compliance.</li> <li>Provide quality support on tech transfers.</li> <li>Liaise with CMO Quality partners to communicate QA policy and procedures.</li> <li>Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.</li> <li>Responsible for material disposition of cell banks, commercial and clinical DS.</li> <li>Review executed batch records and associated documentation for material disposition.</li> <li>Review and approve GMP documentation such as master batch records, deviations, change controls, specif