{"id":3048425,"url":"https://alion.io/job/abbvie-lead-quality-dossier-program-auditor","title":"Lead Quality Dossier Program Auditor","company":{"id":3660,"name":"AbbVie","domain":"abbvie.com","url":"https://alion.io/company/abbvie","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":80,"open_postings":64,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":16,"computed_at":"2026-10-27T05:46:45Z"}},"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":["Chicago, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":109500,"max":208500,"currency":"USD","period":"year","gross":null,"usd_annual":208500},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-22T00:51:25Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-27T06:28:20Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"About AbbVie\nAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.\n The Lead Quality Dossier Program Auditor role supports the Quality Dossier Program audit process by planning and conducting audits required by the Quality Dossier Program. This includes effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process and managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.\nResponsibilities:\nPlan and conduct audits required by the Quality Dossier Program. Audits may be of clinical documents, pre-clinical documents, CMC documents, etc.\nPerform peer reviews of document audits.\nReview audit responses for adequacy, consistency, and compliance\nMaintain the audit schedule\nRepresent RD QA for Dossier Program related meetings/activities/functions as needed.\nRecommend plan of action for satisfactory resolution of quality and regulatory compliance issues\nIdentify and resolve problems through effective interpersonal skills.\nWork independently as well as part of a team\nMaintain effective communication of program related information.\n Bachelor’s degree preferable in a physical science, life science, pharmacy, engineering, or equivalent experience required.\n5+ years’ experience in the Medical Device or Pharmaceutical industry,\nExperience in Quality Assurance or Regulatory Affairs (preferred)\nQuality Assurance auditing experience (preferred)\nPlanning and conducting audits required by the Quality Dossier Program\nEffectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process.\nCoordinating the review and tracking of audit responses and associated tasks across multiple dossier programs.\nManaging other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.\nEscalating potential quality issues to management\nAssist in the management of Due Diligence and Post-Closure Quality Assessment activities in support of projects across one or more aspect of the business.\nAssist in the coordination, review, and tracking of RDQA activities needed to complete Due Diligence and Post-Closure Quality assessments.\n Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:\nThe compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. \nWe offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.\nThis job is eligible to participate in our long-term incentive programs. \nNote: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.\nAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.\nUS & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html\nUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:\nhttps://www.abbvie.com/join-us/reasonable-accommodations.html","description_format":"text","description_chars":4560,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Neurology & CNS Therapeutics","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-22T01:30:25Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 236 · green card filings: 57","filings_12m":236,"filings_prev_12m":256,"green_card_filings_12m":57,"median_offered_wage_usd":150555,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+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":61,"band":"ok","label":"Likely open","p_open":1,"p_active":0.608,"p_room":1,"age_days":5,"expected_fill_days":16,"reasons":["conf:3","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":208500,"is_top_pay":true},"html_url":"https://alion.io/job/abbvie-lead-quality-dossier-program-auditor","json_url":"https://alion.io/job/abbvie-lead-quality-dossier-program-auditor.json","meta":{"generated_at":"2026-10-27T10:03:07Z","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":11475,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":3660},"rest":"https://alion.io/mcp/rest/get_company?id=3660"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabbvie-lead-quality-dossier-program-auditor"},{"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%2Fabbvie-lead-quality-dossier-program-auditor"},{"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%2Fabbvie-lead-quality-dossier-program-auditor"},{"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/abbvie-lead-quality-dossier-program-auditor\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabbvie-lead-quality-dossier-program-auditor"}]}