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Job Description
Associate Director, Country Clinical Quality Manager (CCQM)
Regulations & Processes:
- Local expert for ICH-GCP and local regulations (incl. impact assessment of recent/updated local regulations on local processes).
- In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
- Local expert for any quality-related local processes.
- Identifies process gaps / opportunities for process improvement and properly escalates to Sr. CCQM Lead/RCQM and/or Global Process Owners (if necessary).
- Leads continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and Sr.
CCQM Lead/RCQM and supports or co-leads continuous improvements activities at the global/regional level. Training:
- Local training point of contact and the liaison between local country operations and Learning & Development (L&D;).
- In close cooperation with local country operations management, identifies / coordinates local training needs.
- Supports local trainings (as needed). Quality Control (QC) Activities:
- In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.
- In mutual agreement with local country operations management and the Sr. CCQM Lead/RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.
- On a regular basis and in collaboration with local country operations, identifies local tren