Director, Quality Operations

Company Overview 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. Position Overview The Director, Quality Operations will report to the Senior Director, Quality Assurance and provide strategic operational leadership and oversight across assigned programs related to clinical and commercial. This role will lead day-to-day activities around commercialization of Varegacestat and continuing Varegacestat clinical programs. Additional projects will eventually be added. They will work cross-functionally and with internal and external partners to ensure product quality throughout the development lifecycle and provide strategic quality leadership aligned with company objectives. Experience with small molecules and biologics is required. Responsibilities Quality Operations Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing as well as packaging/labeling activities. Review and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization. Disposition clinical and commercial batches. Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products . Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed. Perform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities. Support vendor qualification program and monitor vendor performance. Prompt communication to management of potential compliance issues. Participate in internal and external project team meetings. Documentation and Record Control Perform periodic reviews and revisions of SOPs, policies, and Quality Agreements to align with regulatory updates and business needs. Establish, review and/or approve Quality Agreements and ensure they are properly stored and managed. Manage other internal and external documentation related to QA operations. Regulatory Compliance and Inspection Readiness Ensure external parties are inspection-ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies. Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance with filing requirements. Support site preparation for regulatory inspections including personnel preparation and training. Participate in Quality Management Review meetings, as needed. Assist in updating CMC sections of regulatory and quality documents. Operational Leadership and Continuous Improvement Drive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality. Provide strategic direction and hands-on leadership for operations teams, ensuring alignment with business goals and regulatory demands. D evelop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvemen…