Job Summary
The Lead Quality Dossier Program Auditor is responsible for organizing and executing audits of clinical, pre-clinical, and CMC documentation to guarantee adherence to regulatory standards. This role also involves overseeing the audit timeline, tracking performance metrics, and acting as a liaison for the department during interdepartmental meetings.
Responsibilities
- Plan and execute audits for clinical, pre-clinical, and CMC documentation.
- Ensure compliance with regulatory requirements through thorough evaluations.
- Manage and maintain the audit schedule and performance metrics.
- Represent the auditing department in cross-functional meetings to communicate findings and updates.
Qualifications
- Bachelor’s degree in a relevant scientific or engineering discipline.
- Minimum of 5 years of experience within the pharmaceutical or medical device industry.
- Preferred extensive knowledge in quality assurance or regulatory affairs.
AbbVie provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
