Clinical Quality Auditor

Job Summary

To ensure compliance with global regulations, the full-time Clinical Quality Auditor will execute the Clinical audit program, including scheduling, planning, and reporting of audits, while working remotely.

Key responsibilities:

• Assure quality and compliance in a regulated environment through continuous evaluation of Clinical processes via audit and QA oversight activities
• Lead and participate in Clinical Audit scheduling, planning, and conducting activities to assess compliance with regulations and AbbVie policies
• Effectively communicate audit results and review Corrective Action Plans submitted in response to audit observations

Required qualifications:

• Bachelor's degree in a science field or healthcare profession, or equivalent experience
• 3-5 years of experience in the biopharmaceutical industry or with a regulatory authority
• 3-5 years of experience in Quality Assurance and/or Clinical Research Development
• High level of awareness and understanding of clinical trial regulations (e.g., ICH-GCP, EU Clinical Trial Directive/Regulation)
• Willingness and ability to perform international travel