Director of Quality Assurance, GCP

Job Summary

A company is looking for a Director, CRO Quality Assurance (GCP).

Key Responsibilities

• Lead, implement, and improve the Quality Management System (QMS) for Compass, ensuring compliance with global regulations
• Oversee the QA audit program and manage vendor quality qualifications and audits
• Provide trends and metrics of the QA program to Executive Management and support compliance activities

Required Qualifications

• University/college degree in a scientific or technical discipline (life science preferred)
• A minimum of ten (10) years of relevant clinical research experience in research site, biotech, pharma, or CRO
• Extensive knowledge of ICH Guidelines and GCP, including international regulatory requirements
• Demonstrated ability to handle multiple competing priorities effectively
• Proficient in Microsoft Word and Excel