Senior Manager, EU Quality Assurance

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.
Overview of Role:
The Senior Manager, EU QA will lead and manage quality assurance activities to ensure compliance with EU GMP, regulatory requirements, and company standards. This role involves oversight of quality systems, batch release processes, audits, and continuous improvement initiatives. The person in this role will act as a key liaison between manufacturing, regulatory, and quality teams to maintain product integrity and patient safety. This position will also provide senior-level oversight of quality systems, support product development and assist in the clinical IMP QP oversite and commercialization process, and ensure that all activities align with Summit’s mission to deliver safe, effective therapies to patients.
Role and Responsibilities:
Oversee remote batch release operations, ensuring real-time quality oversight of manufacturing and testing conducted at global contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs). Manage batch documentation reviews and approvals using digital QMS platforms and electronic batch records (EBRs).
Collaborate with CMOs, CDMOs, and supply chain partners to ensure seamless support to the Qualified Person (QP) in batch certification and release activities.
Ensure timely review and approval of batch records and associated documentation.
Support as the Qualified Person (QP) in the certification and release of IMP product by ensuring that relevant manufacturing, testing, supply chain, and quality documentation is complete, accurate, and available for QP certification.
Coordinate the timely escalation and resolution of quality issues that may affect QP certification.
Maintain and improve the Pharmaceutical Quality System (PQS) in compliance with EU GMP and ICH guidelines.
Oversee CAPA, change control, deviation management, and risk assessments for the EU quality system.
Ensure compliance with EU GMP, ICH guidelines, HPRA, and EMA regulatory requirements.