{"id":3179537,"url":"https://alion.io/job/psc-biotechr-quality-risk-management-lead","title":"Quality Risk Management Lead","company":{"id":4424516,"name":"PSC Biotech®","domain":"biotech.com","url":"https://alion.io/company/psc-biotech","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Zoho Recruit","truth_index":null},"role":"Finance","role_family":"Finance","seniority":"lead","employment_type":"full_time","work_mode":"on_site","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":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"ICH Guidelines","optional":false}],"status":"live","first_seen_at":"2026-10-07T00:00:00Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-11-03T15:11:56Z","board_verified":true,"closed_at":null,"days_open":27,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":27},"description":"About PSC Biotech\nWho are we?\nPSC Biotech is a leading Biotech Consultancy firm founded\nin 1996, headquartered in Pomona, California, USA, with Global operations in\nIreland, India, Singapore, Australia and the US, serving 350 clients in more\nthan 23 countries worldwide. We provide cloud-based software solutions for\nQuality Management and Regulatory Inspections, pharmaceuticals contract\nmanufacturing professionals, and metrology services to our clients.\n‘Take your Career to a new Level’\nPSC Biotech disrupts the conventional consultancy model\nby aligning our EVP as one of the unique selling point which includes the\nopportunity to work with the most talented cohort of like-minded professionals\noperating in the Pharma/ Biotech Industry. We offer a permanent contract of\nemployment giving exposure of working in Top Pharmaceutical client sites in a\ndiverse-cultural work setting.\nEmployee Value Proposition\nEmployees are the “heartbeat” of PSC Biotech, we provide\nunparalleled empowering career development though Learning & Development\nin-house training mentorship through constant guidance to facilitate career\nprogression. We believe in creating high performing teams that can exceed our\nclient’s expectations with regards to quality of all scalable and business unit\ndeliverables, staying under budget and ensuring timelines for our deliverables\nare being met.\nSummary:\nThe QRM lead is responsible for redefining and embedding\na risk-based quality management approach for a new, digitally enabled biologics\nmanufacturing facility. The role ensures that quality risk management is\nsystematically applied across processes, systems, and operations, with\nparticular focus on operational resiliency, digital system dependency, and\npaperless manufacturing continuity.\nRequirements\nEssential Duties and Responsibilities include, but are\nnot limited to, the following:\nDesign and implement a modern, facility-wide Quality RiskManagement (QRM) framework, aligned with ICH Q9(R1), supporting a fully digital\nplant.\n\nEmbed risk-based thinking into all aspects of facilitystartup, including manufacturing processes, digital systems, automation, data\nflows, and quality oversight.\n\nAssess and manage risks related to dependency on digitaland corporate systems, including DCS, MES, eBR, ERP, data historians, and\nnetwork infrastructure.\n\nDefine and govern business continuity and contingencystrategies to ensure GMP compliance during system outages (e.g., network\nfailures, cloud unavailability), including controlled fallback for paperless\noperations.\n\nPartner with Quality, Manufacturing, IT, Automation, andEngineering to ensure risks are proactively identified, mitigated, and owned.\n\nEnsure risk decisions are science-based, documented, andinspection-ready, supporting regulatory confidence in a highly digital\noperating model.\n\nEducation and experience:\nExtensive experience in Quality Risk Management withinGMP-regulated pharma or biologics manufacturing.\n\nStrong knowledge of ICH Q9, digital manufacturingconcepts, and system-enabled operations.\n\nProven ability to operate at a strategic level,influencing site design, operating models, and quality governance.\n\nExperience addressing operational resiliency, dataintegrity, and business continuity in digital or paperless environments.","description_format":"text","description_chars":3287,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Healthcare & Life Sciences Consulting"],"lifecycle":[{"event":"open","at":"2026-10-23T20:54:31Z"}],"visa":[],"liveness":{"score":11,"band":"cold","label":"Long shot","p_open":1,"p_active":0.319,"p_room":0.35,"age_days":27,"expected_fill_days":4,"reasons":["conf:0","win:tail"],"computed_at":"2026-11-03T05:54:40Z"},"pay":null,"html_url":"https://alion.io/job/psc-biotechr-quality-risk-management-lead","json_url":"https://alion.io/job/psc-biotechr-quality-risk-management-lead.json","meta":{"generated_at":"2026-11-03T17:32:57Z","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":24471,"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":4424516},"rest":"https://alion.io/mcp/rest/get_company?id=4424516"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpsc-biotechr-quality-risk-management-lead"},{"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%2Fpsc-biotechr-quality-risk-management-lead"},{"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%2Fpsc-biotechr-quality-risk-management-lead"},{"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/psc-biotechr-quality-risk-management-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpsc-biotechr-quality-risk-management-lead"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3179537}},{"tool":"search_jobs","arguments":{"company":"biotech.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3179537},"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"}}