Local expert for ICH-GCP and local regulations, managing the local network of owners/SMEs for global/local processes to ensure proper implementation and SOP/WI updates
Job Summary
Local expert for ICH-GCP and local regulations, managing the local network of owners/SMEs for global/local processes to ensure proper implementation and SOP/WI updates.
Coordinates and oversees all Quality Control activities, including Inhouse Quality Control Plan and Quality Control Visits, performing trend analysis and root-cause analysis.
Primary point of contact for Quality Assurance and Regulatory Agencies, managing and supporting activities during audits and inspections, and coordinating CAPA management.
Matching Summary
Local expert for ICH-GCP and local regulations, managing the local network of owners/SMEs for global/local processes to ensure proper implementation and SOP/WI updates.
Skills & Requirements
Must-have
ICH-GCP and local regulations expert
Clinical Trial processes knowledge
Quality management and control tools
Continuous improvement leadership
Audit and inspection management
Nice-to-have
Passionate problem solvers
Innovating as a team
Agile and driven to accelerate delivery
Total Self culture
Diversity of thoughts and backgrounds
Key Requirements
Bachelor's Degree or equivalent
6-8 years relevant clinical research experience
Demonstrated experience leading cross-functional teams