Lead Quality Dossier Program Auditor - Hybrid, Chicago

AbbVie; North Chicago (IL); Hybrid; USD 110,000 - 209,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k)

Job summary

AbbVie Inc. is seeking a Lead Quality Dossier Program Auditor in hybrid Chicago to plan and conduct audits under the Quality Dossier Program.

You will interact with Medical Writing, Regulatory Affairs, and Development Sciences and manage audit schedules, metrics, and leadership reporting. The role requires 5+ years in pharma/medical devices, QA auditing experience, and strong coordination across multiple dossier programs.

Qualifications

• 5+ years in Medical Device or Pharmaceutical industry.
• Experience in Quality Assurance or Regulatory Affairs (preferred).
• Experience planning and conducting audits for the Quality Dossier Program.
• Ability to communicate with Medical Writing, Regulatory Affairs, Development Sciences during audits.
• Coordinate review and tracking of audit responses across dossier programs.

Responsibilities

• Plan and conduct Quality Dossier Program audits.
• Perform peer reviews of document audits.
• Review audit responses for adequacy, consistency, and compliance.
• Maintain the audit schedule and reporting metrics.
• Represent RD QA for Dossier Program meetings and activities.

Skills

Audit planning

Quality Assurance

Regulatory affairs

Stakeholder communication

Team collaboration

Education

Bachelor's degree in physical/science field

Equivalent experience in lieu of degree

Job description

Lead Quality Dossier Program Auditor - Hybrid, Chicago

• Full-time
• Salary Min: 109500
• Salary Max: 208500
• Workday Global Grade: 18
• Compensation: USD 109,500 - USD 208,500 - yearly

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.

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.

Responsibilities

• 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.

Qualifications

• 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.

Compensation & Benefits

• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

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.