Lead Quality Dossier Program Auditor - Hybrid, Chicago

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  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.

• 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.