Drive quality improvement in clinical trials as a Clinical Quality Manager at AbCellera. This pivotal role involves supporting trial delivery and ensuring compliance with ICH-GCP standards.
As a Clinical Quality Manager, you will contribute to the successful execution of clinical trials for innovative medicines. Collaborating with teams, you will enhance process improvements, manage risks, and uphold a culture of compliance. Your expertise will be crucial in maintaining GCP inspection readiness and ensuring adherence to regulatory requirements.
Key Responsibilities:
• Write and review SOPs for Phase 1-3 clinical trials
• Perform qualifications of service providers for trials
• Prepare for Health Authority inspections and ensure GCP readiness
• Oversee CAPA and identify process improvement opportunities
• Support project teams with ICH-GCP and regulations
Requirements:
• 8+ years experience, 3+ years in Clinical Quality
• Bachelor’s degree in Pharmaceutical...