{"id":1838282,"url":"https://alion.io/job/lifelancer-senior-qa-auditor-gcp-audits","title":"Senior QA Auditor - GCP Audits","company":{"id":3853997,"name":"Lifelancer","domain":"lifelancer.com","url":"https://alion.io/company/lifelancer","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":true,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"Finance","role_family":"Finance","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":75400,"max":188600,"currency":"USD","period":"year","gross":null,"usd_annual":188600},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-10-04T09:19:29Z","employer_posted_date":null,"last_verified_at":"2026-10-04T09:19:29Z","board_verified":false,"closed_at":null,"days_open":32,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":32},"description":"Job Title: Senior QA Auditor - GCP Audits\nJob Location: Durham, North Carolina, United States of America\nJob Location Type: Remote\nJob Contract Type: Full-time\nJob Seniority Level: \nOverview:\nPlan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.Essential Functions:\n\nPlan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions\n\nEvaluate audit findings and prepare and distribute reports to operations staff, management, and customers\n\nProvide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures\n\nProvide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans\n\nReview, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.\n\nEvaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements\n\nMaintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle\n\nLead/collaborate/support in QA initiatives/projects for quality, process improvements\n\nAssist in training of new Quality Assurance staff\n\nMay be required to manage Quality Issues\n\nMay present educational programs and provide guidance to operational staff on compliance procedures\n\nMay perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.\n\nQualifications:\nBachelor's Degree Pref\n\nTravel 30-50%\n\n5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality\n\nAssurance Audits. GCP experience. Equivalent combination of education, training and experience.\n\nExperienced in the conduct of clinical trial Investigator site audits.\n\nExperience in the conduct of clinical study report/data management/biostatistics clinical trial audits is preferred.\n\nKnowledge of word-processing, spreadsheet, and database applications.\n\nExtensive knowledge of pharmaceutical research and development processes and regulatory environments.\n\nKnowledge of quality assurance processes and procedures.\n\nStrong interpersonal skills.\n\nExcellent problem solving, risk analysis and negotiation skills.\n\nStrong training capabilities.\n\nEffective organization, communication, and team orientation skills.\n\nAbility to initiate assigned tasks and to work independently.\n\nAbility to manage multiple projects.\n\nAbility to establish and maintain effective working relationships with coworkers, managers and clients.\n\nIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at \nIQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. \nIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.\nThe potential base pay range for this role, when annualized, is $75,400.00 - $188,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.\n\nThis job is curated by Lifelancer.Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.\nPlease apply via Lifelancer platform to get connected to the application page and to find similar roles.\nOriginally posted on Himalayas","description_format":"text","description_chars":5396,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Internet Services","Freelance & Talent Marketplaces"],"lifecycle":[{"event":"open","at":"2026-10-04T15:02:40Z"}],"visa":[],"liveness":{"score":15,"band":"cold","label":"Long shot","p_open":0.6,"p_active":0.447,"p_room":0.55,"age_days":32,"expected_fill_days":29,"reasons":["seen:32","agency","velocity","win:tail","comp:brand"],"computed_at":"2026-11-06T05:58:05Z"},"pay":{"stated_usd_annual":188600,"is_top_pay":true},"html_url":"https://alion.io/job/lifelancer-senior-qa-auditor-gcp-audits","json_url":"https://alion.io/job/lifelancer-senior-qa-auditor-gcp-audits.json","meta":{"generated_at":"2026-11-06T08:59:11Z","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":16168,"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":3853997},"rest":"https://alion.io/mcp/rest/get_company?id=3853997"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flifelancer-senior-qa-auditor-gcp-audits"},{"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%2Flifelancer-senior-qa-auditor-gcp-audits"},{"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%2Flifelancer-senior-qa-auditor-gcp-audits"},{"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/lifelancer-senior-qa-auditor-gcp-audits\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flifelancer-senior-qa-auditor-gcp-audits"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1838282}},{"tool":"search_jobs","arguments":{"company":"lifelancer.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1838282},"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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