Drive clinical quality and compliance for creative drugs as a Clinical Quality Manager. Enhance trial delivery and ensure adherence to ICH-GCP guidelines while improving processes and risk management.
In this pivotal role, you will support multi-disciplinary project teams, focusing on quality in international clinical trials. Key responsibilities include writing SOPs, performing qualifications of service providers, and preparing for inspections. Ensure inspection readiness and timely CAPA resolutions meeting regulatory compliance standards.
Key Responsibilities:
• Write and review SOPs for clinical trial activities
• Assess updates to ICH and local guidelines
• Perform service provider qualifications for trials
• Ensure GCP inspection readiness and support inspections
• Oversee CAPA processes and identify improvement opportunities
Requirements:
• 8+ years of relevant experience, including 3+ in Clinical Quality
• Strong knowledge of quality control and process improvement
• Bachelor’s in Pharmaceutical Science or related field
• Bilingual in French and English preferred
• Willingness to travel up to 20% to service sites
Leverage your expertise to elevate clinical trial quality and compliance, ensuring successful drug delivery.
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