Senior Manager of Technical QA (GMP) at Summit Therapeutics in Palo Alto, CA

Job description

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. On-Site 4 days per week at our Palo Alto, CA or Princeton, NJ office Overview of Role: The Senior Manager of Technical QA (GMP) reports to the Senior Director of Technical QA (GMP) and provides comprehensive GMP quality oversight across the product lifecycle for Summit's oncology portfolio. This role supports process validation, continued process verification, technology transfer, comparability assessments, product lifecycle management, and post-approval changes. The Senior Manager serves as the primary quality interface between internal MSAT and Technical Operations teams and external manufacturing partners, ensuring compliance with global GMP requirements while driving continuous improvement and effective change management. The position requires a seasoned quality manager capable of operating at both strategic and tactical levels, with a track record of driving GMP compliance in the development of biologics. ​ Role and Responsibilities: Responsible for providing sponsor oversight of clinical Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories (CTLs) to support clinical manufacture and testing. Responsible for providing sponsor oversight of Contract Testing Laboratories (CTLs) support clinical and commercial product testing, methods, method transfers, method validations, stability, and specifications. Partner with Supplier Quality to monitor quality performance metrics for CMOs, CTLs and critical suppliers, ensuring effective management of quality risks and continuous improvement initiatives. Maintain the Annual Product Quality Review process, including trend analysis, product quality assessments, process performance evaluation and management review reporting. Collaborate with MSAT and Technical Operations teams for Change Controls of process development, technology transfer, scale-up activities, and other manufacturing and analytical changes and provide quality oversight for the Change Control program while ensuring appropriate impact assessments, risk evaluations, implementation plan