Lead Quality Dossier Auditor - Drive Regulatory Excellence

AbbVie; North Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie in North Chicago, IL seeks a Lead Quality Dossier Program Auditor to plan and conduct audits under the Quality Dossier Program. The role collaborates with Medical Writing, Regulatory Affairs, and Development Sciences and reports to Senior Leadership as needed.

Responsibilities include maintaining audit schedules, reviewing responses, and representing RD QA in dossier meetings. Applicants should have 5+ years in pharma/medical device QA, and a degree in a relevant science, with strong

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.
• Effective communication with business partners (e.g., Medical Writing; Regulatory Affairs; Development Sciences).
• Coordinating the review and tracking of audit responses across multiple dossier programs.
• Managing audit schedule, reporting metrics, and presenting to Senior Leadership.

Responsibilities

• Plan and conduct audits required by the Quality Dossier Program, including clinical, pre-clinical, and CMC documents.
• Perform peer reviews of document audits.
• Review audit responses for adequacy, consistency, and compliance.
• Maintain the audit schedule.
• Represent RD QA for Dossier Program meetings/activities/functions.
• Recommend action plans for quality and regulatory issues.
• Identify and resolve problems through interpersonal skills.
• Work independently and as part of a team.
• Maintain communication of program information.

Skills

Auditing

Quality Assurance

Regulatory Affairs

Communication

Project coordination

Teamwork

Problem solving

Education

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

Tools

QA auditing tools

Job description

AbbVie in North Chicago, IL seeks a Lead Quality Dossier Program Auditor to plan and conduct audits under the Quality Dossier Program. The role collaborates with Medical Writing, Regulatory Affairs, and Development Sciences and reports to Senior Leadership as needed.

Responsibilities include maintaining audit schedules, reviewing responses, and representing RD QA in dossier meetings. Applicants should have 5+ years in pharma/medical device QA, and a degree in a relevant science, with strong