Job Description

Associate Director, Country Clinical Quality Manager (CCQM)

Regulations & Processes:
• Local expert for ICH-GCP and local regulations (incl. impact assessment of current/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 trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required).

Audits & Inspection

📌 Associate Director, Country Clinical Quality Manager (Gurugram)
🏢 Msd
📍 Gurugram