Senior Auditor Clinical Affairs

A Senior Auditor at Abbott leads clinical study audits to ensure internal and external sites comply with FDA regulations, ICH GCP, and sponsor requirements. The role involves independent and lead auditor responsibilities, mentoring QA staff, managing contract auditors, and ensuring regulatory compliance for new product approvals. As a subject matter expert, the professional prepares reports, facilitates external inspections, and drives corrective action initiatives to mitigate compliance risks.