{"id":2001436,"url":"https://alion.io/job/cvs-health-gmp-quality-manager","title":"GMP Quality Manager","company":{"id":4223,"name":"CVS Health","domain":"cvshealth.com","url":"https://alion.io/company/cvshealth","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":100,"open_postings":9,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":4,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Dublin, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":50000,"max":125000,"currency":"EUR","period":"year","gross":null,"usd_annual":140659},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-10-07T11:36:25Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-11-03T16:56:39Z","board_verified":true,"closed_at":null,"days_open":27,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":27},"description":"We’re building a world of health around every individual - shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger - helping to simplify health care one person, one family and one community at a time.\nBased in Dublin, Ireland; Cordavis is a wholly owned subsidiary of CVS Health.\nCordavis makes strategic investments to bring pharmaceutical products to the U.S. market to increase competition and lower costs. Cordavis partners with manufacturers and payors to deliver:\nSustainable cost savings for payors and patients.\nA reliable and predictable supply chain that minimizes disruption for patients.\nA responsible and viable long-term approach to deliver value and affordable products.\nOur partnerships create a vibrant and competitive marketplace, allowing us to expand our investments in future products to shape tomorrow's health care, today.\nPosition Summary\nThe Quality Manager is accountable for ensuring that all Manufacturing and CMO activities are conducted in full compliance with Good Manufacturing Practices (GMP), local regulatory requirements, and the conditions set out within Quality Agreements.\nThe role is responsible for overseeing manufacturing activities with suppliers and supports the Quality compliance onsite. The Quality Manager oversees the Quality Management System (QMS) for GMP / GCP operations, ensuring it is maintained, effective, and continuously improved. The Quality Manager provides quality leadership, governance, and assurance across CMO-related activities, supporting a sustainable culture of compliance and inspection readiness\nKey Responsibilities:\nAssist in Quality Assurance department in all GXP functional areas (GMP, GLP, GCP, GXP document control, GXP training)\nCollaborate with team members on the implementation and management of GXP quality and compliance systems and policies, including the development of QA and GMP / GDP processes and procedures\nAssist in ensuring the company is regulatory inspection ready at all times (Regulatory Agencies and Client)\nReview drug substance, drug product, Finished product executed batch records. Collaborate with CMOs to resolve issues, and support release of product.\nPerform transport duty of care and release for acceptance checks as necessary\nSupport approaches to implement quality standards and procedures for GXP regulatory compliance to meet company needs\nOversee performance of Suppliers and Service Providers\nConduct supplier qualification and quality audits of CMOs, including audit follow up, review of observation responses, CAPA management, and tracking.\nSupport development of Quality Agreements with CMOs\nCollaborate with team, regulatory, and client representatives in audits and inspections\nProvide guidance and training to cross-functional departments on relevant GMP regulations and guidelines.\nSupport the implementation and utilization of electronic document management system(s).\nRepresent Quality on cross functional project teams to ensure adherence to cGMP and compliance standards.\nConduct internal and external audits to ensure compliance with GCP regulatory requirements and GMP regulatory requirements for commercial drug manufacturing, and ensure corrective actions are implemented to resolve audit findings\nManaging regulatory change control processes in the QMS\nMaintain pertinent domestic and international regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.\nCollaborating with the external publishing vendor for e-submission files and compendia submission\nAssist Complaint Investigations with Manufacturing sites and distributors.\nPerformance of Annual Product Quality Reviews\nExecution on Quality System tools: Change Controls, Deviations, CAPAs, Risk Assessments\nLeads QA function product launches prior to distribution of the product\nQA Oversight of artwork changes.\nQualifications, Experience and Skills:\nMinimum of a Bachelors’ degree, ideally in a bio-chemistry, life sciences, or microbiology related field; Advanced degree will be given preference, however, extensive industry experience acceptable in lieu of advanced degree\n5-7 years of experience in positions of responsibility within Quality Assurance\nExperience with documentation systems, document review and auditing responsibilities\nKnowledge of relevant regulations, including FDA, EU GMP (ideally sterile manufacturing)\nMust be a proactive problem solver, well organized, team player with good follow through\nStrong background in Quality Management Systems ideally eQMS,\nMust be able to handle and prioritize multiple responsibilities and meet deadlines in a fast paced environment.\nUnderstanding of virtual wholesaling and CMO oversight.\nPay Range\nThe typical pay range for this role is:\n€50,000.00 - €125,000.00We anticipate the application window for this opening will close on: 22/11/2026","description_format":"text","description_chars":5275,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Ireland","iso":"IE","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Primary Care & Medical Centers","Pharmacies","Health Insurance & Benefits"],"lifecycle":[{"event":"open","at":"2026-10-07T11:36:25Z"}],"visa":[],"liveness":{"score":14,"band":"cold","label":"Long shot","p_open":1,"p_active":0.392,"p_room":0.35,"age_days":26,"expected_fill_days":4,"reasons":["conf:0","velocity","win:tail","comp:brand"],"computed_at":"2026-11-03T05:54:40Z"},"pay":{"stated_usd_annual":140659,"is_top_pay":false},"html_url":"https://alion.io/job/cvs-health-gmp-quality-manager","json_url":"https://alion.io/job/cvs-health-gmp-quality-manager.json","meta":{"generated_at":"2026-11-03T19:44:16Z","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":2128,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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":4223},"rest":"https://alion.io/mcp/rest/get_company?id=4223"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcvs-health-gmp-quality-manager"},{"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%2Fcvs-health-gmp-quality-manager"},{"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%2Fcvs-health-gmp-quality-manager"},{"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/cvs-health-gmp-quality-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcvs-health-gmp-quality-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2001436}},{"tool":"search_jobs","arguments":{"company":"cvshealth.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2001436},"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. Docs: https://alion.io/developers"}}