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Senior Specialist, QA

Summittherapeutics · Ireland, Switzerland

<div class="content-intro"> 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) <ul> <li> 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. </li> </ul> <ul> <li> 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. </li> </ul> <ul> <li> HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. </li> </ul> Colorectal Cancer (CRC) <ul> <li> HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. </li> </ul> 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. </div>Overview of Role:  The Senior Specialist, QA will provide operational leadership and quality oversight for the review, approval and release-readiness of clinical and commercial product batches.  The role is responsible for ensuring that batch documentation is complete, accurate, traceable, and compliant with applicable GMP requirements, approved procedures and regulatory commitments before submission to QA for final disposition or QP certification. The person will coordinate batch-release activities across Quality, Manufacturing, Supply Chain, Regulatory Affairs and external manufacturing partners, ensuring that issues are identified, escalated and resolved in a timely manner. The position will also lead process improvements, support inspection readiness and promote high standards of data integrity and Good Documentation Practice across the batch-release process.  Key Responsibilities  <ul> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Batch Review and Release Readiness </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-a

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