Sr. Clinical QA Auditor

We are seeking an experienced Senior Clinical QA Auditor to support and lead quality assurance activities across clinical trials within a fast-paced CRO environment. The individual will serve as a subject matter expert in GCP compliance, driving audit strategy, inspection readiness, and continuous quality improvement across sponsors, sites, and internal processes.

Requirements

• Lead and execute GCP audits
• Plan, conduct, and report onsite and remote audits
• Design and lead mock FDA/EMA inspections
• Provide onsite audit support during regulatory inspections
• Perform and oversee TMF quality reviews and audits
• Identify compliance risks, trends, and gaps
• Act as a trusted advisor to sponsors
• Contribute to the development and continuous improvement of QA processes
• Participate in review of internal and external Quality Issues and Corrective and Preventive Action plans

Benefits

• Health and welfare benefits
• Incentive plans
• Bonuses