GCP Quality Assurance Leader

Job Summary

A company is looking for a Fractional VP of Quality.

Key Responsibilities

• Lead GCP quality assurance, including audit program design, inspection readiness, and compliance with regulations
• Oversee the Integrated Management System and ensure quality documentation is accurate and practical
• Manage and develop a small team while collaborating with clinical operations and other departments on quality matters

Required Qualifications

• Significant hands-on experience in GCP quality assurance and auditing
• Strong knowledge of ICH GCP, FDA regulations, and EU/UK clinical trial regulations
• Experience in preparing for regulatory inspections and audits
• Ability to develop and maintain a GCP quality management system
• Experience with eQMS platforms and managing small teams