Description

In this role, you will partner with cross-functional teams to drive GCP/GVP compliance, identify clinical trial risks, and support audits. You'll oversee quality aspects of clinical studies, prepare for regulatory inspections, and improve the company's risk-based compliance approach.

Requirements

• Bachelor's Degree or higher in a scientific discipline
• Minimum 8 years relevant experience in Quality Assurance in pharmaceutical or biotech
• Strong understanding of clinical trials and pharmacovigilance reporting
• In-depth knowledge of GCP, EU, FDA, and ICH regulations
• Experience leading internal and external QA audits and developing risk-based audit plans

Responsibilities

• Perform internal and external audits to ensure GCP/GVP compliance
• Provide auditing activities including preparation, execution, report preparation, and follow-up
• Partner with QA leadership during regulatory authority inspections and drive inspection readiness
• Oversee quality aspects related to clinical study start-up, execution, and close-out
• Manage Quality Management System (QMS) including deviations, CAPAs, and change controls