GCP Quality Assurance Director

Job Summary

A company is looking for a Director of Clinical Quality to lead their Quality function across GCP Quality Assurance and Business Quality.

Key Responsibilities

• Lead GCP quality assurance, including auditing, inspection readiness, and compliance with regulations
• Oversee the Integrated Management System and ensure quality documentation is accurate and practical
• Manage a small team and collaborate with clinical operations leadership to embed quality across the organization

Required Qualifications

• At least 10 years of experience in GCP quality assurance, including audit planning and execution
• Experience with ICH GCP, FDA regulations, and ideally EU/UK clinical trial regulations
• Proven track record of preparing for regulatory inspections and audits
• Experience developing and maintaining a GCP quality management system
• Familiarity with eQMS platforms and the ability to manage and develop a small team