Auditor, RDQA Clinical Quality Audit - Remote

Role: Clinical Quality Assurance Specialist focused on the execution of the Clinical audit program within AbbVie's regulated environment. Responsibilities: plan, schedule, and conduct audits (investigator sites, processes, systems, affiliates); communicate audit findings; review and approve Corrective Action Plans; contribute to development of the Clinical QA quality system; support GCP inspections and provide GCP compliance guidance; promote ongoing education on clinical regulations. Requirements: Bachelor’s in science or health care; 3-5 years in biopharma or regulatory agency; 3-5 years in Quality Assurance and/or Clinical Research; strong knowledge of ICH-GCP, EU Clinical Trial Directive/Regulation; analytical skills; ability to work independently in a dynamic environment; effective communication and project management skills. High-Value: clinical audits in GCP-regulated environment, investigator sites, process and system audits, international travel up to 40%. WorkSetup: travel up to 40%; location not specified but implied global/remote flexibility.