{"id":3150490,"url":"https://alion.io/job/weilgroup-senior-gmp-data-integrity-and-computerized-systems-compliance-consultant","title":"Senior GMP Data Integrity and Computerized Systems Compliance Consultant","company":{"id":4465740,"name":"Weil Group, Inc","domain":"weilgroup.com","url":"https://alion.io/company/weilgroup","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"CATS","truth_index":null},"role":"Legal","role_family":"Legal","seniority":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Manatí, Puerto Rico"],"countries":["PR"],"hiring_countries":["PR"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":68000,"max_usd":186000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":2992},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-23T12:03:04Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-11-06T08:03:24Z","board_verified":true,"closed_at":null,"days_open":13,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":13},"description":"Weil Group Inc. is identifying qualified consultants for a proposed pharmaceutical manufacturing quality-system assessment. This project-based opportunity is subject to project award and client confirmation.Assess whether GMP records preserve their content, context, integrity and traceability throughout creation, review, transfer, retention and use in Quality decisions.\nWhat you will do\nReview original electronic, paper and hybrid records and relevant metadata.\nEvaluate audit trails, access, changes, electronic signatures, review practices and record retention.\nDevelop evidence-based findings and feasible controls with Quality, Laboratory, Manufacturing and IT.\nMandatory requirements\nHands-on assessment of original GMP records and metadata in pharmaceutical or biologics operations.\nPractical review of audit trails, user access, attribution, changes, electronic signatures and data review before release.\nAbility to assess applicability and controls under 21 CFR Part 11 and EU GMP Annex 11 together with the underlying GMP record requirements.\nExperience with manufacturing or laboratory systems and the connection of their records to Quality processes.\nAbility to identify incomplete records, unreconciled transcription and limitations in review-by-exception practices.\nProfessional English for technical records, deliverables and stakeholder discussions.\nAvailability for assigned on-site work in Manatí, Puerto Rico, with approved remote work where appropriate.\nAbility to meet confidentiality, site and information-handling requirements and disclose potential conflicts affecting independent assessment.\nNecessary qualifications\nTypically 7 or more years of directly relevant professional experience, or a demonstrably equivalent track record.\nEvaluate validated state, change control, incidents, periodic review, retention, recovery and supplier controls.\nDesign risk-based audit-trail review criteria and workable controls for hybrid records.\nRelevant education or equivalent practical experience in quality, pharmaceutical science, engineering or computerized-system compliance.\nDesired qualifications\nExperience across both laboratory data and electronic manufacturing records.\nGAMP, system-auditing or data-integrity training; experience with the platforms confirmed for the project.\nParticipation in data-integrity improvements with measured outcomes and working Spanish.\nHow to apply\nApply through this posting with your CV, relevant project examples, current location, availability for work in Manatí and proposed hourly or daily consulting rate. Assignment scope, duration and terms will be confirmed with selected consultants.\n**Weil Group is proud to be an Equal Employment Opportunity Employer.**","description_format":"text","description_chars":2724,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Puerto Rico","iso":"PR","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-23T12:03:04Z"}],"visa":[],"liveness":{"score":16,"band":"cold","label":"Long shot","p_open":1,"p_active":0.361,"p_room":0.45,"age_days":13,"expected_fill_days":7,"reasons":["conf:2","agency","win:tail"],"computed_at":"2026-11-06T05:58:05Z"},"pay":null,"html_url":"https://alion.io/job/weilgroup-senior-gmp-data-integrity-and-computerized-systems-compliance-consultant","json_url":"https://alion.io/job/weilgroup-senior-gmp-data-integrity-and-computerized-systems-compliance-consultant.json","meta":{"generated_at":"2026-11-06T09:59:25Z","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":18133,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":4465740},"rest":"https://alion.io/mcp/rest/get_company?id=4465740"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fweilgroup-senior-gmp-data-integrity-and-computerized-systems-compliance-consultant"},{"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%2Fweilgroup-senior-gmp-data-integrity-and-computerized-systems-compliance-consultant"},{"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%2Fweilgroup-senior-gmp-data-integrity-and-computerized-systems-compliance-consultant"},{"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/weilgroup-senior-gmp-data-integrity-and-computerized-systems-compliance-consultant\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fweilgroup-senior-gmp-data-integrity-and-computerized-systems-compliance-consultant"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3150490}},{"tool":"search_jobs","arguments":{"company":"weilgroup.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3150490},"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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