Senior Specialist, QA at Summit Therapeutics, Inc.

National University of Ireland, Galway, IrelandFull-timeQuality & RA CMCPosted 3 days ago

About the Role

<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-aria-posinset="1" data-aria-level="2">Coordinate the end-to-end QA review of executed batch manufacturing, packaging, testing and release documentation for IMP and Commercial biological batch records. </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-aria-posinset="2" data-aria-level="2">Coordinate the preparation and collation of batch documentation required for final batch disposition or QP certification from internal and external sources. </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-aria-posinset="3" data-aria-level="2">Verify that batch records are complete, accurate, and compliant with approved procedures, specifications and applicable GMP requirements. </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-aria-posinset="4" data-aria-level="2">Confirm that relevant deviations, investigations, change controls, CAPAs, and laboratory results have been appropriately assessed and approved before release. </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-aria-posinset="5" data-aria-level="2">Identify documentation gaps, discrepancies and potential compliance risks, and coordinate their timely resolution. </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-aria-posinset="6" data-aria-level="2">Maintain oversight of batch-release priorities, review status, outstanding actions, and planned release dates. </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-aria-posinset="7" data-aria-level="2">Escalate critical issues or potential delays to Quality leadership and relevant stakeholders. </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-aria-posinset="8" data-aria-level="2">Ensure that batch-release documentation is appropriately archived and readily retrievable electronically. </li> </ul>   <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="2" data-aria-level="1">Quality Systems and Compliance: </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-aria-posinset="1" data-aria-level="2">Ensure batch-release activities are performed in accordance with current GMP, Good Documentation Practice, data-integrity principles, and internal procedures. </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-aria-posinset="2" data-aria-level="2">Support the effective operation of quality systems associated with deviations, CAPAs, change controls, document control, and training. </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-aria-posinset="3" data-aria-level="2">Review and approve relevant quality documents, including SOPs, work instructions, forms, checklists, and batch-release procedures. </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-aria-posinset="4" data-aria-level="2">Maintain controlled documentation and ensure that current approved versions are available to relevant personnel. </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-aria-posinset="5" data-aria-level="2">Support periodic reviews of procedures and identify opportunities to strengthen compliance and operational effectiveness. </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-aria-posinset="6" data-aria-level="2">Promote the appropriate use of electronic quality and document management systems. </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-aria-posinset="7" data-aria-level="2">Act as a subject-matter expert for batch documentation, release-readiness and associated document-control processes for all batch release activities. </li> </ul> <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="3" data-aria-level="1">Internal Team Coordination (EU QA) </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-aria-posinset="1" data-aria-level="2">Provide day-to-day leadership and technical guidance to QA batch reviewers and supporting personnel. </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-aria-posinset="2" data-aria-level="2">Plan and allocate batch-review activities according to business priorities, product demand, and release timelines. </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-aria-posinset="3" data-aria-level="2">Monitor team workload, quality metrics, and completion of assigned activities. </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-aria-posinset="4" data-aria-level="2">Develop and deliver training in Good Documentation Practice, batch-record review and relevant quality-system processes. </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-aria-posinset="5" data-aria-level="2">Support onboarding and qualifications of new QA team members. </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-aria-posinset="6" data-aria-level="2">Foster a collaborative, accountable, and continuous-improvement culture within the QA function. </li> </ul>   <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="4" data-aria-level="1">External Team Collaboration: </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-aria-posinset="1" data-aria-level="2">Work closely with Manufacturing, Quality Control / CMC, Supply Chain, Regulatory Affairs, Clinical Supply and other relevant functions to support timely batch release. </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-aria-posinset="2" data-aria-level="2">Coordinate with all Summit CMOs, testing laboratories and service providers to obtain missing documents and resolve release-related queries. </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-aria-posinset="3" data-aria-level="2">Communicate batch status, risks, priorities and outstanding actions clearly to internal and external stakeholders. </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-aria-posinset="4" data-aria-level="2">Support changes affecting batch documentation or release processes. </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-aria-posinset="5" data-aria-level="2">Participate in cross-functional meetings concerning batch disposition, documentation, readiness, and supply continuity internally. </li> </ul>   <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" 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">Inspection Readiness and Continuous Improvement </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="2">Maintain batch-release processes and supporting records in a continuous state of inspection of readiness. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="2">Support regulatory inspections, customer audits, internal audits, and supplier audits. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="2">Retrieve and present batch documentation and quality-system records during audits and inspections. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="2">Track batch-review metrics, recurring documentation issues, cycle times, and overdue actions. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="2">Analyse trends and recommend improvements to increase efficiency, right-first-time performance and compliance. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="2">Lead or contribute to Lean and process-optimization initiatives within the batch-release function. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="2">Support the implementation and enhancement of electronic quality, document management and reporting systems. </li> </ul> Qualifications and Experience  <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Essential </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="2">Recognized qualification in Quality, Pharmaceutical Science, Life Sciences, Engineering or related discipline. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="2">Significant experience in Quality Assurance within a pharmaceutical, biopharmaceutical or similarly regulated manufacturing environment – preferably in Biologic manufacturing, Packaging and Labelling environments.  </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="2">Practical experience reviewing executed batch records and supporting batch disposition or QP certification activities. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="2">Knowledge of GMP, Good Documentation Practice, and data-integrity requirements. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="2">Experience working with deviations, investigations, CAPAs, and change controls. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="2">Experience using electronic quality, document management and other enterprise-systems - systems such as MasterControl, NetSuite, Veeva Vault, TrackWise, SAP or equivalent platforms. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="2">Demonstrated ability to coordinate multiple priorities and deliver against critical release timelines. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="2">Experience supporting the release of medicinal products or investigational medicinal products. </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="2">Experience working with contract manufacturing organizations and external testing laboratories </li> </ul>   <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":360,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Key Competencies </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="2">Strong attention to detail and documentation accuracy </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="2">Sound quality and compliance judgement </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="2">Leadership and team coordination </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="2">Effective prioritization and workload management </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="2">Problem-solving and risk-based decision-making </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="2">Clear communication and stakeholder management </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="2">Audit and inspection readiness </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="2">Data integrity and information governance </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="2">Process improvement and operational efficiency </li> </ul> <ul> <li data-leveltext="o" data-font="Courier New" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Courier New","469769242":[9675],"469777803":"left","469777804":"o","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="2">Ability to work independently in a fast-paced environment </li> </ul><div class="content-conclusion">  Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at <a href="mailto:[email protected]" target="_blank">[email protected]</a> to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.</div>

About the Role

Related Roles