New · posted Nov 14
AbbVie · Pharmaceuticals
Lead Quality Dossier Program Auditor
- North Chicago, IL
- Hybrid
- Full-time
- Senior & Principal
The role
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.
What you need
What you'll do
- Plan and conduct audits required by the Quality Dossier Program. Audits may be of clinical documents, pre-clinical documents, CMC documents, etc.
- Perform peer reviews of document audits.
- Review audit responses for adequacy, consistency, and compliance
- Maintain the audit schedule
- Represent RD QA for Dossier Program related meetings/activities/functions as needed.
- Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
- Identify and resolve problems through effective interpersonal skills.
- Work independently as well as part of a team
- Maintain effective communication of program related information.
- Bachelor’s degree preferable in a physical science, life science, pharmacy, engineering, or equivalent experience required.
- 5+ years’ experience in the Medical Device or Pharmaceutical industry,
- Experience in Quality Assurance or Regulatory Affairs (preferred)
- Quality Assurance auditing experience (preferred)
- Planning and conducting audits required by the Quality Dossier Program
- Effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process.
- Coordinating the review and tracking of audit responses and associated tasks across multiple dossier programs.
- Managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.
- Escalating potential quality issues to management
- Assist in the management of Due Diligence and Post-Closure Quality Assessment activities in support of projects across one or more aspect of the business.
- Assist in the coordination, review, and tracking of RDQA activities needed to complete Due Diligence and Post-Closure Quality assessments.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The 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.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
Pay and benefits
$110,000 – $209,000 a year
Employer providedPaid time off
Medical insurance
Dental insurance
Vision insurance
401(k)
Long-term incentive programs
Where you'll work
North Chicago, ILHybridOpen in Maps (opens in a new tab)
More jobs in North Chicago, IL
From the posting
About AbbVie
AbbVie'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.
Equal opportunity, accessibility and legal noticesAbbVie's statements, word for word
AbbVie 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.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Job intelligence
The context around this role
Live data · November 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 21% above the US median for Quality Auditing roles at this level.
This roleEmployer provided
Senior & Principal roles in the US10 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $110,000 | — | $209,000 |
| All US (middle half) | $114,625 | $132,000 | $159,500 |
This role: AbbVie's own published range. Comparisons: the base pay employers published on open Quality Auditing roles at the same level on Regulatory Jobs, November 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Auditing
The general path across 26 open Quality Auditing roles on Regulatory Jobs, with the titles they carry most. Not AbbVie's own promotion track.
Career resources on Quality Auditing
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance11
- Collaboration and leadership6
- Regulatory submissions5
- Documentation and SOPs4
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Auditing work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- WHOWHO good manufacturing practices(official source, opens in a new tab)World Health Organization GMP norms and standards for medicines
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
Company hiring pulse
AbbVie on Regulatory Jobs
- 72
- Open roles
- 72
- Distinct roles
- 16
- Locations
By discipline
- Clinical60 52%
- Quality29 25%
- Regulatory27 23%
By level
- Director51 44%
- Manager35 30%
- Senior & Principal16 14%
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Lead Quality Dossier Program Auditor at AbbVie
Open until filled. $110K–$209K a year, employer provided.