{"id":3330843,"url":"https://alion.io/job/ecolab-quality-and-compliance-regulated-software-systems","title":"Quality and Compliance Regulated Software Systems","company":{"id":1754712,"name":"Ecolab","domain":"ecolab.com","url":"https://alion.io/company/ecolab-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":147,"ghost_share":0,"stale_share":0.755,"repost_share":0.007,"time_to_fill_p50_days":27,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Management","role_family":"Management","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Eagan, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":107600,"max":161500,"currency":"USD","period":"year","gross":null,"usd_annual":161500},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"Agile","optional":false},{"name":"AWS","optional":true},{"name":"Azure","optional":true},{"name":"GCP","optional":true},{"name":"ISO 13485","optional":true}],"status":"live","first_seen_at":"2026-10-26T00:00:00Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-11-11T06:53:14Z","board_verified":true,"closed_at":null,"days_open":16,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":16},"description":"We are seeking a Quality & Compliance Manager to lead the quality assurance and regulatory compliance efforts for a new cloud-native software platform being developed for a highly regulated industry. This role will be instrumental in ensuring that our software development lifecycle, deployment processes, and product releases meet all applicable regulatory requirements, including GxP and FDA 21 CFR Part 11.\nAs the Quality & Compliance Manager, you will work closely with internal leadership and external development partners to define and enforce quality standards, oversee validation activities, and ensure that our systems are built and maintained in a state of control. This is a hands-on role that combines quality leadership with practical execution of validation and compliance processes.\nWhat you will do:\nDefine and implement the quality and compliance strategy for a regulated software product, including validation planning, risk management, and change control.\n\nEnsure all software development and deployment activities comply with applicable regulations (e.g., FDA 21 CFR Part 11, GxP, GAMP 5).\n\nLead the Computer System Validation (CSV) process, including authoring and reviewing validation plans, test protocols (IQ/OQ/PQ), traceability matrices, and validation summary reports.\n\nCollaborate with internal product and engineering leads to embed quality and compliance requirements into the software development lifecycle (SDLC).\n\nReview and approve documentation, including user requirements, functional specifications, and design documents, to ensure traceability and audit readiness.\n\nOversee the implementation of audit trails, electronic signatures, access controls, and data integrity features in the product.\n\nCoordinate with external development partners to ensure quality standards and validation deliverables are met.\n\nSupport internal and external audits, including preparation of documentation and responses to findings.\n\nEstablish and maintain a quality management system (QMS) for software development and deployment activities.\n\nProvide training and guidance to internal and external teams on quality and compliance best practices.\n\nQualifications:\nBachelor’s degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences, or Quality Management).\n\n8 years of experience in software quality assurance or compliance roles, with at least 3 years in a regulated industry (e.g., life sciences, medical devices, healthcare).\n\nDeep understanding of GxP, FDA 21 CFR Part 11, and Computer System Validation (CSV) principles.\n\nExperience with validation of cloud-based and/or SaaS software platforms.\n\nFamiliarity with Agile and DevOps methodologies, and how to adapt them for compliance in regulated environments.\n\nStrong documentation skills and experience with validation artifacts (e.g., URS, FRS, test protocols, traceability matrices).\n\nExcellent communication and collaboration skills, with the ability to work across internal teams and external partners.\n\nNo immigration sponsorship is available for this role at this time.\n\nPreferred Qualifications:\nExperience with GAMP 5, ISO 13485, or other relevant quality frameworks.\n\nFamiliarity with cloud platforms (Azure preferred; AWS or GCP also valued).\n\nExperience supporting regulatory inspections or audits (e.g., FDA, EMA).\n\nKnowledge of AI/ML systems and their validation in regulated environments is a plus.\n\nAnnual or Hourly Compensation Range\nThe base salary range for this position is $107,600.00 - $161,500.00. This position is eligible for annual bonus pay based on performance, per plan terms. Many factors are taken into consideration when determining compensation, such as experience, education, training, geography, etc. We comply with all minimum wage and overtime laws.Benefits\nEcolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families. Click here to see our benefits.\nIf you are viewing this posting on a site other than our Ecolab Career website, view our benefits at jobs.ecolab.com/working-here.\nPotential Customer Requirements Notice\nTo meet customer requirements and comply with local or state regulations, applicants for certain customer-facing roles may need to:\n- Undergo additional background screens and/or drug/alcohol testing for customer credentialing.\nAmericans with Disabilities Act (ADA)\nEcolab will provide reasonable accommodation (such as a qualified sign language interpreter or other personal assistance) with our application process upon request as required to comply with applicable laws. If you have a disability and require accommodation assistance in this application process, please visit the Recruiting Support link in the footer of each page of our career website.","description_format":"text","description_chars":4773,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cleaning & Household Products","Chemical Manufacturing","Food Safety","Sterilization & Infection Control"],"lifecycle":[{"event":"open","at":"2026-10-27T12:01:59Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 20 · green card filings: 6","filings_12m":20,"filings_prev_12m":36,"green_card_filings_12m":6,"median_offered_wage_usd":142885,"route":null,"cap_exempt":false,"checked_at":"2026-11-10T11:34:35+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":55,"band":"ok","label":"Likely open","p_open":1,"p_active":0.613,"p_room":0.9,"age_days":16,"expected_fill_days":27,"reasons":["conf:4","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-11-11T05:49:22Z"},"pay":{"stated_usd_annual":161500,"is_top_pay":true},"html_url":"https://alion.io/job/ecolab-quality-and-compliance-regulated-software-systems","json_url":"https://alion.io/job/ecolab-quality-and-compliance-regulated-software-systems.json","meta":{"generated_at":"2026-11-11T07:38:08Z","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":11700,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-12T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":1754712},"rest":"https://alion.io/mcp/rest/get_company?id=1754712"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fecolab-quality-and-compliance-regulated-software-systems"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fecolab-quality-and-compliance-regulated-software-systems"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fecolab-quality-and-compliance-regulated-software-systems"},{"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/ecolab-quality-and-compliance-regulated-software-systems\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fecolab-quality-and-compliance-regulated-software-systems"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3330843}},{"tool":"search_jobs","arguments":{"company":"ecolab.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3330843},"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. 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