Senior GCP Process Auditor

📋 Description

• Support the Quality Management System including SOPs, training and CAPA
• Host client/sponsor audits and support regulatory inspections
• Coordinate and conduct internal audits of quality systems
• Coordinate and conduct investigator site audits
• Coordinate and conduct trial master file audits
• Follow applicable regulations and standards, including FDA and EU, ICH

🎯 Requirements

• Extensive experience managing audits, especially GCP Process Audits
• Working knowledge of GCP/ICH guidelines and FDA regulations
• Bachelor’s degree in science, healthcare, or related field
• Willingness to travel up to 25% domestically and internationally
• QA certification preferred (e.g., CQA, SQA)
• Experience with electronic trial systems (EDC, CTMS, IxRS, ePRO)