{"id":1310262,"url":"https://alion.io/job/replimune-director-qualified-person","title":"Director, Qualified Person","company":{"id":2285234,"name":"Replimune","domain":"replimune.com","url":"https://alion.io/company/replimune","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":null},"role":"HR","role_family":"HR","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Abingdon, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":125000,"max_usd":228000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":22},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-14T20:58:15Z","employer_posted_date":"2026-09-14","last_verified_at":"2026-10-20T19:11:54Z","board_verified":true,"closed_at":null,"days_open":35,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":35},"description":"Overview\nReplimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care becausepatient’s lives depend on it.\nAt Replimune, we live by our values:\nUnited: We Collaborate for a Common Goal.\nAudacious: We Are Bold.\nDedicated: We Give Our Full Commitment.\nCandid: We Are Honest With Each Other.\nPeople are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.\nJoin us, as we reshape the future.\nJob Summary:\nThe Qualified Person (QP) must fulfil duties in compliance with Eudralex Volume 4, Annex 16, Certification by a Qualified Person and Batch Release.\nThe QP is responsible for ensuring that each individual batch of product has been manufactured and checked in compliance with laws in force in the UK or EU Member State where certification takes place, as applicable, in accordance with the requirements of Good Manufacturing Practice (GMP) and in compliance with the relevant marketing authorisation or clinical trial authorisation and product specification file, including clinical trial protocol, for a given product and associated trial.\nThis position is based in our Milton Park location and typically has minimally a 3 day on-site expectation. (hybrid)\nThe QP must personally ensure that the following operational responsibilities are fulfilled prior to certification of a batch for release to market or for export in the EU and UK:\n\nCertification is permitted under the terms of the manufacturers importation authorisation.\n\nAny additional duties and requirements of national legislation are complied with.\n\nCertification is recorded in a register or equivalent\n\nAssessment of each batch for certification prior to release may include batch records, QC data, associated records/quality systems, production conditions, cleaning records, examination of the finished packs, results of any importation testing where relevant, stability, shipping data, audits, documents certifying the authorisation of a manufacturer, relevant regulatory and GMP requirements, verification of the supply chain and all other factors the QP is aware of as relevant to the quality of the batch.\n\nThe QP shall ensure that products are manufactured and/or imported appropriately by applying manufacturing practice which ensures the quality of such medicinal products in order to safeguard the safety of the subject/patient and the reliability and robustness of clinical data.\n\nThe QP shall ensure there are appropriate pharmaceutical quality systems in place as it relates to GMP, and should have a broad knowledge of pharmaceutical development and the clinical trial process.\n\nSpecifically, the QP or a delegate shall confirm the following:\n\nAll manufacturing and quality control activities have been conducted according to the principles of GMP\n\nThe full supply chain for the product is documented and available to the QP\n\nAll external audits have been performed as appropriate and are available\n\nAll sites involved in the manufacture, quality control, distribution, and certification of the products are listed in the applicable application and are licensed as required\n\nAll sites involved in the manufacture, quality control, distribution, and certification of the products are in compliance with the relevant application\n\nAll manufacturing activities and testing activities are consistent with those described in the application\n\nThe sources and specifications of the starting materials and packaging materials are in compliance with the applicable regulatory application\n\nThe active pharmaceutical ingredient is manufactured and distributed according to GMP\n\nThe active pharmaceutical ingredient has been imported as appropriate\n\nThe excipients have been manufactured in accordance with requirements\n\nThe TSE status of materials used are consistent with those described in the application\n\nAll records are complete and endorsed by appropriate All required in-process controls and checks have been made\n\nAll manufacturing and testing processes remain in the validated state\n\nPersonnel are trained and qualified as appropriate\n\nThe finished product quality control test data complies with the specification in the applicable regulatory application\n\nAny post-marketing commitments relating to manufacturing or testing have been addressed. Ongoing stability data continues to support certification\n\nThe impact of any change to manufacturing or testing has been evaluated, and any additional checks/tests are complete\n\nAll batch-specific investigations have been completed to a sufficient level to support certification\n\nAny ongoing complaints, investigations, or recalls do not negate the conditions for certification of each batch\n\nThe required technical agreements are in place\n\nThe self-inspection programme is active and current\n\nThe appropriate arrangements for distribution and shipment are in place\n\nWhere appropriate, safety features have been affixed\n\nOther Responsibilities:\nCertification of the finished product batch signifying that the batch is in compliance with GMP and the requirements of its marketing authorisation or clinical trial authorisation and product specification file.\n\nConfirmation that the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation product specification file as applicable and the principles and guidelines of GMP.\n\nTake a lead role in any quality defects as referred to in Chapter 8 of Eudralex, Volume 4, Part I (Complaints and Product Recall) and Part IV (Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products)\n\nOversee batch review of Replimune clinical and commercial products for use in the EU and UK.\n\nExecute batch disposition of Replimune clinical and commercial products for release in the EU and UK.\n\nAssess applicable deviations, quality defects, change controls, complaints, product labels, as appropriate.\n\nProvide support to the company and its staff to drive continual\n\n· Education:\n· B.A or B.S. degree in an appropriate scientific M.S., Ph.D. or other post¬ graduate degree is encouraged.\n· Required Experience:\n·\nEligible as Qualified Person satisfying the provisions of Article 49 of 2001/83/EC 06 November 2001.\nMaintain up to date regulatory and industry knowledge through program of Continuous Professional Development. Experience and Skill Requirements:\nKnowledge of EU and UK regulations and guidelines regarding GMPs.\nSufficient industry experience no less than two (2) years of experience within relevant pharmaceutical fields.\nExperience with steriles required and Advanced Therapy Medicinal Products (ATMP) preferred.\n·\n· About Replimune\nReplimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.\n· We are an Equal Opportunity Employer.\nAbout Replimune\nReplimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.\nWe are an Equal Opportunity Employer.","description_format":"text","description_chars":8959,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development"],"hiring_locations":[{"name":"United Kingdom","iso":"GB","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-26T15:39:31Z"}],"visa":[{"country":"GB","licensed_sponsor":true,"evidence":"Licensed UK visa sponsor (Skilled Worker, Senior or Specialist Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Skilled Worker; Global Business Mobility: Senior or Specialist Worker","cap_exempt":false,"checked_at":"2026-10-20T06:21:30+00:00","sources":["UK Home Office: register of licensed sponsors (workers)"],"filings_for_role_12m":0}],"liveness":{"score":77,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.858,"p_room":0.9,"age_days":35,"expected_fill_days":51,"reasons":["conf:3","win:mid"],"computed_at":"2026-10-20T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/replimune-director-qualified-person","json_url":"https://alion.io/job/replimune-director-qualified-person.json","meta":{"generated_at":"2026-10-20T20:56:30Z","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":24350,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"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":2285234},"rest":"https://alion.io/mcp/rest/get_company?id=2285234"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Freplimune-director-qualified-person"},{"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%2Freplimune-director-qualified-person"},{"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%2Freplimune-director-qualified-person"},{"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/replimune-director-qualified-person\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Freplimune-director-qualified-person"}]}