Director of GCP Compliance

Job Summary

A company is looking for a Director of GCP Compliance.

Key Responsibilities

• Develop and direct the strategy for Clinical QC, Controlled Document/Training, and Continuous Improvement teams
• Manage regulatory inspection activities, including preparation, execution, and response strategies
• Oversee the development and maintenance of Quality Management documents and corporate training programs

Required Qualifications

• Master's or Bachelor's degree in a health or science-related field
• 6-8 years of experience in Quality, audit, or inspection hosting in a regulated industry
• Advanced knowledge of clinical development programs and quality management systems
• Comprehensive understanding of GCP/GVP/ICH and worldwide Regulatory Health Authority requirements
• Experience managing Quality Management programs, including CAPA management solutions