{"id":2508705,"url":"https://alion.io/job/smmttx-senior-specialist-qa","title":"Senior Specialist, QA","company":{"id":21096,"name":"Summit Therapeutics","domain":"smmttx.com","url":"https://alion.io/company/smmttx","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":87,"open_postings":3,"ghost_share":0,"stale_share":0.333,"repost_share":0,"time_to_fill_p50_days":62,"computed_at":"2026-10-28T05:59:10Z"}},"role":"QA","role_family":"QA","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Dublin, Ireland","Ireland","United Kingdom","Switzerland"],"countries":["IE","GB","CH"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":51000,"max_usd":143000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1282},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-10-08T14:01:31Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-28T15:50:27Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"description":"About Summit:\nSummit 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.\nSummit’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:\nNon-small Cell Lung Cancer (NSCLC)\nHARMONi: 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.\n\nHARMONi-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.\n\nHARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.\n\nColorectal Cancer (CRC)\nHARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.\n\nIvonescimab 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.\nOverview of Role: \nThe Senior Specialist, QA will provide operational leadership and quality oversight for the review, approval and release-readiness of clinical and commercial product batches. \nThe 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. \nKey Responsibilities \nBatch Review and Release Readiness \nCoordinate the end-to-end QA review of executed batch manufacturing, packaging, testing and release documentation for IMP and Commercial biological batch records. \nCoordinate the preparation and collation of batch documentation required for final batch disposition or QP certification from internal and external sources. \nVerify that batch records are complete, accurate, and compliant with approved procedures, specifications and applicable GMP requirements. \nConfirm that relevant deviations, investigations, change controls, CAPAs, and laboratory results have been appropriately assessed and approved before release. \nIdentify documentation gaps, discrepancies and potential compliance risks, and coordinate their timely resolution. \nMaintain oversight of batch-release priorities, review status, outstanding actions, and planned release dates. \nEscalate critical issues or potential delays to Quality leadership and relevant stakeholders. \nEnsure that batch-release documentation is appropriately archived and readily retrievable electronically. \nQuality Systems and Compliance: \nEnsure batch-release activities are performed in accordance with current GMP, Good Documentation Practice, data-integrity principles, and internal procedures. \nSupport the effective operation of quality systems associated with deviations, CAPAs, change controls, document control, and training. \nReview and approve relevant quality documents, including SOPs, work instructions, forms, checklists, and batch-release procedures. \nMaintain controlled documentation and ensure that current approved versions are available to relevant personnel. \nSupport periodic reviews of procedures and identify opportunities to strengthen compliance and operational effectiveness. \nPromote the appropriate use of electronic quality and document management systems. \nAct as a subject-matter expert for batch documentation, release-readiness and associated document-control processes for all batch release activities. \n Internal Team Coordination (EU QA) \nProvide day-to-day leadership and technical guidance to QA batch reviewers and supporting personnel. \nPlan and allocate batch-review activities according to business priorities, product demand, and release timelines. \nMonitor team workload, quality metrics, and completion of assigned activities. \nDevelop and deliver training in Good Documentation Practice, batch-record review and relevant quality-system processes. \nSupport onboarding and qualifications of new QA team members. \nFoster a collaborative, accountable, and continuous-improvement culture within the QA function. \nExternal Team Collaboration: \nWork closely with Manufacturing, Quality Control / CMC, Supply Chain, Regulatory Affairs, Clinical Supply and other relevant functions to support timely batch release. \nCoordinate with all Summit CMOs, testing laboratories and service providers to obtain missing documents and resolve release-related queries. \nCommunicate batch status, risks, priorities and outstanding actions clearly to internal and external stakeholders. \nSupport changes affecting batch documentation or release processes. \nParticipate in cross-functional meetings concerning batch disposition, documentation, readiness, and supply continuity internally. \nInspection Readiness and Continuous Improvement \nMaintain batch-release processes and supporting records in a continuous state of inspection of readiness. \nSupport regulatory inspections, customer audits, internal audits, and supplier audits. \nRetrieve and present batch documentation and quality-system records during audits and inspections. \nTrack batch-review metrics, recurring documentation issues, cycle times, and overdue actions. \nAnalyse trends and recommend improvements to increase efficiency, right-first-time performance and compliance. \nLead or contribute to Lean and process-optimization initiatives within the batch-release function. \nSupport the implementation and enhancement of electronic quality, document management and reporting systems. \nQualifications and Experience \nEssential \nRecognized qualification in Quality, Pharmaceutical Science, Life Sciences, Engineering or related discipline. \nSignificant experience in Quality Assurance within a pharmaceutical, biopharmaceutical or similarly regulated manufacturing environment - preferably in Biologic manufacturing, Packaging and Labelling environments. \nPractical experience reviewing executed batch records and supporting batch disposition or QP certification activities. \nKnowledge of GMP, Good Documentation Practice, and data-integrity requirements. \nExperience working with deviations, investigations, CAPAs, and change controls. \nExperience using electronic quality, document management and other enterprise-systems - systems such as MasterControl, NetSuite, Veeva Vault, TrackWise, SAP or equivalent platforms. \nDemonstrated ability to coordinate multiple priorities and deliver against critical release timelines. \nExperience supporting the release of medicinal products or investigational medicinal products. \nExperience working with contract manufacturing organizations and external testing laboratories \nKey Competencies \nStrong attention to detail and documentation accuracy \nSound quality and compliance judgement \nLeadership and team coordination \nEffective prioritization and workload management \nProblem-solving and risk-based decision-making \nClear communication and stakeholder management \nAudit and inspection readiness \nData integrity and information governance \nProcess improvement and operational efficiency \nAbility to work independently in a fast-paced environment \nActual 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.\nSummit 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  to obtain prior written authorization before referring any candidates to Summit.\nSummit 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.","description_format":"text","description_chars":9658,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-14T08:31:45Z"}],"visa":[],"liveness":{"score":85,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.85,"p_room":1,"age_days":19,"expected_fill_days":62,"reasons":["conf:4","win:early"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/smmttx-senior-specialist-qa","json_url":"https://alion.io/job/smmttx-senior-specialist-qa.json","meta":{"generated_at":"2026-10-28T18:02:54Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":24699,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":21096},"rest":"https://alion.io/mcp/rest/get_company?id=21096"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsmmttx-senior-specialist-qa"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fsmmttx-senior-specialist-qa"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fsmmttx-senior-specialist-qa"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/smmttx-senior-specialist-qa\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsmmttx-senior-specialist-qa"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2508705}},{"tool":"search_jobs","arguments":{"company":"smmttx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2508705},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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