Lead Quality Dossier Program Auditor - Hybrid, Chicago

📋 Description

• Plan and conduct audits required by the Quality Dossier Program.
• 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.

🎯 Requirements

• Bachelor’s degree preferable in a physical science, life science, pharmacy, engineering, or
• 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, e.g., Medical Writing; Regulatory

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Long-term incentive programs