Clinical Quality Assurance Director

Job Summary

Reporting to the Executive Director of Quality Assurance, the remote Associate Director, Clinical Quality Assurance will manage quality oversight of clinical development activities, ensuring compliance with regulatory requirements and supporting risk-based decision-making across clinical programs.

Key responsibilities:

• Serve as the Clinical Quality Assurance representative on clinical study teams, ensuring alignment with GCP and regulatory expectations
• Oversee clinical quality events and CAPAs, conducting root cause analysis and identifying systemic quality trends
• Analyze quality signals to identify emerging risks and recommend mitigation strategies, while contributing to the clinical audit program governance

Required qualifications:

• Bachelor's degree in life sciences, pharmacy, or 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, including Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP)
• Experience in quality management of clinical trials, CAPA management, and regulatory inspection readiness
• Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered a plus