Lead Quality Dossier Program Auditor

Lake County, IL, United States
Sep 16, 2020
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Lead Quality Dossier Program Auditor is an incumbent capable of planning and conducting audits required by the Quality Dossier Program; and managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Sr. Leadership, etc. Additional expectations include supporting supplier management activities, including metrics, CAPA and quality agreements.

  • Complete audits required by the Quality Dossier Program, such as clinical quality, safety, efficacy and non-clinical summaries, and pre-clinical and clinical reports, risk management plans for EU dossiers and other applicable documents, such as Investigator's Brochures.
  • Perform peer reviews of document audits.
  • Maintain the audit schedule and audit metrics,
  • Represent R&D QA for Dossier Program related meetings/activities/functions as needed.
  • Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
  • This is an experienced level compliance position that reports to the Director of Supplier Management, Dossier Audits and Integration. This individual is expected to identify and resolve problems through effective interpersonal skills.
  • Serve as alternate to supplier management program leads in support of supplier corrective actions, supplier metrics, change notifications and quality agreement support.

  • Bachelor's degree with related health science or quality background
  • Advanced degree preferred
  • Minimum 5 years pharma experience; 1-3 years should be quality and management experience
  • Quality Assurance auditing experience (preferred)
  • Demonstration of strong leadership competencies, proficient level of technical capabilities and independence.
  • Understanding of international GxP regulatory standards (e.g. GMP, GLP, GCP, GDP, etc.)

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.