Senior Director, Development Quality Assurance

Role: Senior Director, Development Quality Assurance, overseeing quality strategies to support Immunome's clinical-stage oncology programs, ensuring compliance with GCP, GLP, GVP, and global regulations. Responsibilities: lead quality oversight across clinical development, vendor management, inspection readiness, and continuous process improvement; develop and maintain QMS; support regulatory inspections; implement audit programs; and leverage advanced analytics and AI for risk assessment and process enhancement. Requirements: Bachelor's or Master's in Life Sciences; 15+ years in biotech/pharma quality or clinical development; 5+ years leading quality teams; extensive experience with biologics, ADCs, radiopharmaceuticals, or small molecules; deep knowledge of GxP, FDA, EMA, ICH guidelines; proven success in global inspection readiness and quality system implementation. HighValue: biologics, ADCs, radioligands, regulatory oversight, inspection management, advanced technology integration (AI/ML), global programs. WorkSetup: Not specified, but implies a leadership role with significant cross-functional collaboration.