Senior Clinical Quality Manager

Job Summary

Supporting quality oversight of clinical activities, the remote Senior Manager, Clinical Quality Assurance will manage clinical quality assurance activities to ensure compliance with GCP and corporate standards while interfacing with various departments and regulatory agencies.

Key responsibilities

• Ensure proper conduct of all processes contributing to clinical trial performance
• Prepare and manage the Drug Development Quality Management Plan, including risk management and audit readiness
• Evaluate audit findings and oversee corrective actions while ensuring inspection readiness of regulated activities

Required qualifications

• Bachelor's degree with 12 years of experience or Master's degree with 5 years of experience in clinical quality assurance
• Over 5 years of clinical quality-related experience in the biotech/pharmaceutical industry
• Expert knowledge of GCP, ICH guidelines, and relevant regulatory requirements
• Experience with clinical quality requirements in Europe and in the oncology therapeutic area
• Proven management experience with remote and cross-functional teams