Senior Quality Dossier Program Auditor

Internationalinsuranceprofessionals; Chicago (IL); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

401(k)

Job summary

AbbVie in Chicago seeks a Lead Quality Dossier Program Auditor to plan and conduct audits for the Quality Dossier Program. You will collaborate with Medical Writing, Regulatory Affairs, Development Sciences, and other partners to ensure timely, accurate audits and reporting to leadership.

The role requires strong audit planning, attention to detail, and the ability to manage multiple dossier programs while maintaining the audit schedule and providing metrics-driven updates to Senior Leadership.

Qualifications

• Bachelor's degree 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 during the audit process
• Coordinating the review and tracking of audit responses across multiple dossier programs
• Managing other aspects of the audit program including maintaining the audit schedule and reporting metrics
• Escalating potential quality issues to management

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 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.

Skills

QA auditing

Regulatory Affairs

Medical Writing liaison

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in physical science / life science / pharmacy / engineering

Job description

AbbVie in Chicago seeks a Lead Quality Dossier Program Auditor to plan and conduct audits for the Quality Dossier Program. You will collaborate with Medical Writing, Regulatory Affairs, Development Sciences, and other partners to ensure timely, accurate audits and reporting to leadership.

The role requires strong audit planning, attention to detail, and the ability to manage multiple dossier programs while maintaining the audit schedule and providing metrics-driven updates to Senior Leadership.