{"id":2550875,"url":"https://alion.io/job/cpl-quality-risk-management-lead","title":"Quality Risk Management Lead","company":{"id":2268173,"name":"Cpl","domain":"cpl.com","url":"https://alion.io/company/cpl-com","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":{"grade":"B","score":80,"open_postings":27,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":19,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Finance","role_family":"Finance","seniority":"lead","employment_type":"contractor","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Limerick, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-14T14:44:22Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-22T01:50:13Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"Role: QRM Lead - Digital Core Implementation\nLocation: Raheen, Limerick (Onsite / Hybrid)\nType: 12-Month Initial Contract Immediate and January start dates will be considered.\nRole Overview\nAt CPL we are supporting a large multinational Pharma company that are seeking an experienced Quality Risk Management (QRM) Lead to support the implementation of a digitally enabled manufacturing environment within a leading biopharmaceutical facility.\nThis position will act as the Quality Risk Management subject matter expert, establishing and embedding risk-based quality principles across manufacturing operations, digital systems, automation platforms and quality governance processes.\nThe successful candidate will work cross-functionally with Quality, Manufacturing, Engineering, Automation and IT teams to ensure risks are effectively identified, assessed and mitigated throughout the facility lifecycle.\nKey Responsibilities\nLead the implementation and ongoing management of the site Quality Risk Management (QRM) programme\nFacilitate complex risk assessments using appropriate methodologies including FMEA and risk-ranking approaches\nEmbed risk-based decision making across manufacturing, automation, quality systems and facility start-up activities\nPartner with Quality, Manufacturing, Engineering, Automation and IT teams to identify and mitigate operational and compliance risks\nDevelop and maintain risk management strategies for digital manufacturing and business-critical systems\nAssess risks associated with MES, eBR, DCS, ERP platforms, data historians and supporting infrastructure\nSupport operational resilience, business continuity and data integrity initiatives within a paperless manufacturing environment\nEnsure quality risk decisions are scientifically justified, documented and inspection-ready\nSupport change controls, investigations and quality impact assessments from a risk management perspective\nProvide QRM expertise during internal audits, regulatory inspections and major project reviews\nEssential Requirements\nDegree in Science, Engineering, Quality, Pharmaceutical Sciences or a related discipline\nExtensive experience within GMP-regulated pharmaceutical or biologics manufacturing environments\nStrong working knowledge of ICH Q9(R1) Quality Risk Management principles\nProven experience leading and facilitating complex risk assessments across cross-functional teams\nExperience working with Quality Systems, Change Control, CAPA and GMP compliance programmes\nStrong understanding of digital manufacturing and system-enabled operations\nExperience supporting or governing MES, eBR, DCS, ERP, CSV or Data Integrity programmes\nExcellent stakeholder management and communication skills\nAbility to influence decision-making across Quality, Manufacturing, Automation and Engineering functions\nHighly Desirable\nPrevious experience establishing or managing site-wide QRM programmes\nExperience with PAS-X, Syncade, DeltaV, PI Historian, SAP or similar digital manufacturing platforms\nData Integrity, Computer System Validation (CSV) or Computer Software Assurance (CSA) experience\nExperience supporting facility start-up, expansion or major transformation projects\nOperational resilience or business continuity experience within GMP environments\nBiologics or sterile manufacturing experience\nPrevious regulatory inspection experience involving FDA, EMA or HPRA\nLean Six Sigma or other continuous improvement qualifications\nExperience\n8+ years' experience in Quality Assurance, Quality Systems, Validation, Compliance or Quality Risk Management within the pharmaceutical or biotechnology sector\nDemonstrated experience leading risk-based quality initiatives in highly regulated GMP 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