<div class="content-intro"><p></p>
<p><strong>About Summit:</strong></p>
<p>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.</p>
<p>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:</p>
<p><strong>Non-small Cell Lung Cancer (NSCLC)</strong></p>
<ul>
<li>
<p>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.</p>
</li>
</ul>
<ul>
<li>
<p>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.</p>
</li>
</ul>
<ul>
<li>
<p>HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.</p>
</li>
</ul>
<p><strong>Colorectal Cancer (CRC)</strong></p>
<ul>
<li>
<p>HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.</p>
</li>
</ul>
<p><em>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.</em></p>
<p></p></div><p><strong><span data-contrast="none">Overview of Role:</span></strong><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559739":240,"335559740":240}"> </span></p>
<p><span data-contrast="auto">The Senior Specialist, QA will provide operational leadership and quality oversight for the review, approval and release-readiness of clinical and commercial product batches.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></p>
<p><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></p>
<p><strong><span data-contrast="auto">Key Responsibilities</span></strong><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></p>
<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"><strong><span data-contrast="auto">Batch Review and Release Readiness</span></strong><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Coordinate the end-to-end QA review of executed batch manufacturing, packaging, testing and release documentation for IMP and Commercial biological batch records.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Coordinate the preparation and collation of batch documentation required for final batch disposition or QP certification from internal and external sources.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Verify that batch records are complete, accurate, and compliant with approved procedures, specifications and applicable GMP requirements.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Confirm that relevant deviations, investigations, change controls, CAPAs, and laboratory results have been appropriately assessed and approved before release.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Identify documentation gaps, discrepancies and potential compliance risks, and coordinate their timely resolution.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Maintain oversight of batch-release priorities, review status, outstanding actions, and planned release dates.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Escalate critical issues or potential delays to Quality leadership and relevant stakeholders.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Ensure that batch-release documentation is appropriately archived and readily retrievable electronically.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></li>
</ul>
<p><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":1080,"335559740":240}"> </span></p>
<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"><strong><span data-contrast="auto">Quality Systems and Compliance:</span></strong><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Ensure batch-release activities are performed in accordance with current GMP, Good Documentation Practice, data-integrity principles, and internal procedures.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Support the effective operation of quality systems associated with deviations, CAPAs, change controls, document control, and training.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Review and approve relevant quality documents, including SOPs, work instructions, forms, checklists, and batch-release procedures.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Maintain controlled documentation and ensure that current approved versions are available to relevant personnel.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Support periodic reviews of procedures and identify opportunities to strengthen compliance and operational effectiveness.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Promote the appropriate use of electronic quality and document management systems.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Act as a subject-matter expert for batch documentation, release-readiness and associated document-control processes for all batch release activities.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><strong><span data-contrast="auto">Internal Team Coordination (EU QA)</span></strong><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Provide day-to-day leadership and technical guidance to QA batch reviewers and supporting personnel.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Plan and allocate batch-review activities according to business priorities, product demand, and release timelines.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Monitor team workload, quality metrics, and completion of assigned activities.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Develop and deliver training in Good Documentation Practice, batch-record review and relevant quality-system processes.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Support onboarding and qualifications of new QA team members.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Foster a collaborative, accountable, and continuous-improvement culture within the QA function.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></li>
</ul>
<p><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":1080,"335559740":240}"> </span></p>
<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"><strong><span data-contrast="auto">External Team Collaboration:</span></strong><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Work closely with Manufacturing, Quality Control / CMC, Supply Chain, Regulatory Affairs, Clinical Supply and other relevant functions to support timely batch release.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Coordinate with all Summit CMOs, testing laboratories and service providers to obtain missing documents and resolve release-related queries.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Communicate batch status, risks, priorities and outstanding actions clearly to internal and external stakeholders.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Support changes affecting batch documentation or release processes.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Participate in cross-functional meetings concerning batch disposition, documentation, readiness, and supply continuity internally.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></li>
</ul>
<p><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":1080,"335559740":240}"> </span></p>
<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"><strong><span data-contrast="auto">Inspection Readiness and Continuous Improvement</span></strong><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Maintain batch-release processes and supporting records in a continuous state of inspection of readiness.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Support regulatory inspections, customer audits, internal audits, and supplier audits.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Retrieve and present batch documentation and quality-system records during audits and inspections.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Track batch-review metrics, recurring documentation issues, cycle times, and overdue actions.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Analyse trends and recommend improvements to increase efficiency, right-first-time performance and compliance.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Lead or contribute to Lean and process-optimization initiatives within the batch-release function.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Support the implementation and enhancement of electronic quality, document management and reporting systems.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></li>
</ul>
<p><strong><span data-contrast="auto">Qualifications and Experience</span></strong><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></p>
<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"><strong><span data-contrast="auto">Essential</span></strong><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Recognized qualification in Quality, Pharmaceutical Science, Life Sciences, Engineering or related discipline.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Significant experience in Quality Assurance within a pharmaceutical, biopharmaceutical or similarly regulated manufacturing environment – preferably in Biologic manufacturing, Packaging and Labelling environments. </span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Practical experience reviewing executed batch records and supporting batch disposition or QP certification activities.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Knowledge of GMP, Good Documentation Practice, and data-integrity requirements.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Experience working with deviations, investigations, CAPAs, and change controls.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Experience using electronic quality, document management and other enterprise-systems - systems such as MasterControl, NetSuite, Veeva Vault, TrackWise, SAP or equivalent platforms.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Demonstrated ability to coordinate multiple priorities and deliver against critical release timelines.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Experience supporting the release of medicinal products or investigational medicinal products.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Experience working with contract manufacturing organizations and external testing laboratories</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></li>
</ul>
<p><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":1080,"335559740":240}"> </span></p>
<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"><strong><span data-contrast="auto">Key Competencies</span></strong><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Strong attention to detail and documentation accuracy</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Sound quality and compliance judgement</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Leadership and team coordination</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Effective prioritization and workload management</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Problem-solving and risk-based decision-making</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Clear communication and stakeholder management</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Audit and inspection readiness</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Data integrity and information governance</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Process improvement and operational efficiency</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></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"><span data-contrast="auto">Ability to work independently in a fast-paced environment</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":240}"> </span></li>
</ul><div class="content-conclusion"><p> </p>
<p>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.</p>
<p>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 ----- ----- obtain prior written authorization before referring any candidates to Summit.</p>
<p><span data-teams="true">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.</span></p></div>
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