Lead Quality Dossier Auditor: QA & Regulatory Lead

AbbVie Inc.; North Chicago (IL); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie Inc. in Illinois seeks a Lead Quality Dossier Program Auditor to plan and conduct audits across clinical, pre-clinical and CMC documents within the Quality Dossier Program.

You will partner with Medical Writing, Regulatory Affairs and Development Sciences, coordinate audit responses, and present metrics to Senior Leadership. The role requires a Bachelor’s degree in a physical or life science or related field and 5+ years in the medical device or pharmaceutical industry with QA or

Qualifications

• Bachelor’s degree in physical or life sciences, pharmacy, engineering, or equivalent.
• 5+ years in Medical Device or Pharmaceutical industry.
• Experience in Quality Assurance or Regulatory Affairs preferred.
• Quality Assurance auditing experience preferred.
• Plan and conduct audits for the Quality Dossier Program.
• Communicate with business partners during audits.
• Coordinate review and tracking of audit responses across dossiers.
• Manage audit program aspects: schedule, metrics, leadership presentations.
• Escalate quality issues to management.
• Support Due Diligence and Post-Closure QA activities.

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.

Skills

Quality Assurance

Regulatory Affairs

Auditing

Communication

Project coordination

Teamwork

Education

Bachelor’s degree

Job description

AbbVie Inc. in Illinois seeks a Lead Quality Dossier Program Auditor to plan and conduct audits across clinical, pre-clinical and CMC documents within the Quality Dossier Program.

You will partner with Medical Writing, Regulatory Affairs and Development Sciences, coordinate audit responses, and present metrics to Senior Leadership. The role requires a Bachelor’s degree in a physical or life science or related field and 5+ years in the medical device or pharmaceutical industry with QA or