Clinical Quality Assurance Director

Job Summary

A company is looking for an Associate Director, Clinical Quality Assurance.

Key Responsibilities

• Serve as the Clinical Quality Assurance representative on clinical study teams, ensuring compliance with GCP and regulatory expectations
• Oversee clinical quality events, investigations, and CAPAs, ensuring effective root cause analysis and corrective actions
• Analyze quality signals across studies and vendors to identify risks and recommend mitigation strategies

Required Qualifications

• Bachelor's degree in life sciences, pharmacy, or a related scientific discipline; advanced degree preferred
• Approximately 8+ years of industry experience in clinical quality oversight or quality governance
• Strong knowledge of global GxP regulations applicable to clinical development, including GCP, GVP, and GLP
• Experience with quality management of clinical trials, CAPA management, and regulatory inspection readiness
• Relevant certifications such as RQAP, CQA, CCRC, or RAC are a plus