Clinical Quality Assurance Director

Job Summary

Leading the Clinical Quality Assurance team, the full-time salaried Clinical Quality Assurance Director will ensure compliance with ICH GCP and relevant regulations while managing key business relationships and driving quality initiatives in a remote environment.

Key responsibilities

• Support the implementation of the global quality strategy relevant to GCP across clinical development
• Manage CQA programs to ensure clinical studies adhere to regulations and Jazz standards
• Lead regulatory inspection readiness activities and collaborate with cross-functional teams for process improvement

Required qualifications

• Bachelor's degree in science or a related discipline; post-graduate degree preferred
• 14+ years of relevant experience in the Pharmaceutical or Biotechnology industry
• Established Clinical Quality Professional with demonstrable CQA compliance experience
• Deep understanding of GCP regulations and risk management in clinical trials
• Experience in audit principles, procedures, and techniques