Senior Director of Technical QA (GMP)

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, Princeton, NJ or Miami, FL offices Overview of Role: The Senior Director QA will report to the Vice President, Quality Assurance and Regulatory CMC, and provide comprehensive GMP quality oversight across the full chemistry, manufacturing, and controls (CMC) lifecycle for Summit’s oncology pipeline. The Senior Director will serve as the primary quality interface between internal CMC Technical Operations and external manufacturing partners and will play a pivotal role in supporting clinical and commercial readiness milestones. The Sr.

Director will focus on readiness for BLA filing, and PLI readiness. This position requires a seasoned quality leader capable of operating at both strategic and tactical levels, with a track record of driving GMP compliance in the development of biologics.

Responsibilities

: Responsible for providing sponsor oversight of Contract Manufacturing Organizations (CMO) to support clinical and commercial manufacture. Collaborate with MSAT team on process development, technology transfer, scale-up activities, and other manufacturing changes and provide quality oversight and input. QA Lead for Process Performance Qualification (PPQ/PV), Cleaning Validation, Equipment Qualification (IQ/OQ/PQ), and Computer System Validation (CSV) activities.

Lead and ensure GMP inspection readiness activities for Summit and external CMOs and manage all regulatory inspections in collaboration with relevant stakeholders Mentoring other individuals within the organization in the area of compliance. Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions as appropriate Serve as the primary GMP quality lead for CMC regulatory submissions, including IND, IMPD, BLA/MAA modules and ensure all CMC documentation are accurate.