{"id":1755314,"url":"https://alion.io/job/sire-life-sciences-senior-gmp-quality-engineer","title":"Senior GMP Quality Engineer","company":{"id":2218112,"name":"SIRE Life Sciences","domain":"sire-search.com","url":"https://alion.io/company/sire-search","size_band":"51-200","is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":null,"truth_index":{"grade":"B","score":75,"open_postings":27,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-23T05:54:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Leiden, Netherlands"],"countries":["NL"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":53000,"max_usd":90000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":73},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-06-04T00:00:00Z","employer_posted_date":"2026-10-03","last_verified_at":"2026-10-03T19:50:44Z","board_verified":false,"closed_at":null,"days_open":141,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":141},"description":"The CompanyOur client is a global healthcare and life sciences organization with a strong presence in the Netherlands, focused on developing innovative therapies and vaccines to address major global health challenges. The company operates in a highly regulated, technology-driven environment and promotes a collaborative culture centered on innovation, quality, and continuous improvement.\nAbout the Role:\nThis role is focused on leading quality investigations within a pharmaceutical manufacturing environment, ensuring product quality, compliance, and operational excellence. The Senior Quality Engineer manages non-conformance investigations, CAPA activities, and change controls while identifying root causes and implementing corrective actions. The position collaborates closely with cross-functional teams to maintain regulatory compliance, improve processes, and ensure timely closure of quality records.\nResponsibilities:\n- Lead and manage quality investigations, including non-conformances, root cause analysis, and resolution of quality issues.\n- Oversee CAPA and Change Control processes to ensure timely implementation of corrective and preventive actions.\n- Review and maintain quality documentation, ensuring compliance with GMP, regulatory requirements, and internal standards.\n- Conduct risk assessments, implement mitigation plans, and drive continuous quality improvement initiatives.\n- Coordinate cross-functional teams, monitor investigation progress, and communicate risks, findings, and outcomes to stakeholders and management.\nRequirements:\n- Relevant Bachelor's (HBO) degree with 7-10 years of experience in Quality Engineering, investigations, or pharmaceutical manufacturing.\n- Strong experience managing non-conformance investigations, CAPA activities, and Change Control processes within a GMP-regulated environment.\n- Proven expertise in root cause analysis, risk assessment, problem-solving, and continuous improvement methodologies.\n- Excellent stakeholder management, communication, and cross-functional team coordination skills with the ability to manage multiple priorities.\n- Proficiency in MS Office, data analysis, and quality systems, combined with strong organizational skills and English language proficiency (B2+).\nOther Information:\nLooking for a new opportunity? Well, it's right here! If you're interested, please click the below button to apply for the job.\n58148","description_format":"text","description_chars":2408,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-03T10:30:45Z"}],"visa":[],"liveness":{"score":2,"band":"cold","label":"Long shot","p_open":0.4,"p_active":0.135,"p_room":0.28,"age_days":141,"expected_fill_days":36,"reasons":["conf:466","agency","stale_co","win:tail","crowd:brand"],"computed_at":"2026-10-23T05:54:15Z"},"pay":null,"html_url":"https://alion.io/job/sire-life-sciences-senior-gmp-quality-engineer","json_url":"https://alion.io/job/sire-life-sciences-senior-gmp-quality-engineer.json","meta":{"generated_at":"2026-10-23T13:08:10Z","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":19526,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"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":2218112},"rest":"https://alion.io/mcp/rest/get_company?id=2218112"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsire-life-sciences-senior-gmp-quality-engineer"},{"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%2Fsire-life-sciences-senior-gmp-quality-engineer"},{"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%2Fsire-life-sciences-senior-gmp-quality-engineer"},{"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/sire-life-sciences-senior-gmp-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsire-life-sciences-senior-gmp-quality-engineer"}]}