Associate Director / Director, Supplier Quality and Audits
Immunome, Inc.About the role
<div class="content-intro"><p><strong><u>Company Overview</u></strong></p> <div class="x_elementToProof" data-olk-copy-source="MessageBody"> <div data-olk-copy-source="MessageBody">Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.</div> </div></div><p><span style="text-decoration: underline;"><strong><span data-contrast="auto">Position Overview</span></strong></span></p> <p><span data-contrast="auto">The Director / Associate Director, Supplier Quality and Audits supports the Head of GMP Quality Compliance in building and continuously improving Immunome’s Supplier Quality Compliance and Audit Program. </span><span data-ccp-props="{"201341983":0,"335559740":257}"> </span></p> <p><span data-contrast="auto">This role leads supplier audit management, vendor governance, compliance monitoring, risk management, quality agreements, CAPA management, and inspection readiness for GxP suppliers and service providers, including CDMOs, CROs, contract laboratories, consultants, and other outsourced partners. It ensures supplier compliance and audit processes are risk-based, inspection-ready, and aligned with regulatory requirements and Immunome’s Quality Management System, while maintaining an effective audit program and governance of outsourced GxP activities. </span><span data-ccp-props="{"201341983":0,"335559740":257}"> </span></p> <p><span data-contrast="auto">As a virtual biotechnology company, Immunome retains ultimate responsibility for the quality and compliance of outsourced operations, and this role is a key partner in ensuring audit effectiveness, governance, and inspection readiness across the product lifecycle. This role partners closely with Quality Operations, which manages day-to-day supplier oversight, while this position provides independent compliance oversight through risk assessments, audi
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