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Country Clinical Quality Manager
hace 2 meses
We are seeking a highly skilled and experienced Clinical Quality Manager to join our team at MSD. As a key member of our Country Operations team, you will play a critical role in ensuring the delivery of high-quality clinical trials and compliance with company requirements and regulations.
Key Responsibilities- Oversee all Clinical Quality Management activities in the respective country/cluster, working closely with the Regional Director, Clinical Quality Management (RCQM).
- Implement local/global processes and procedures, identify opportunities for process improvement, and support continuous improvement initiatives.
- Support audits, inspections, Quality Control, and local training activities.
- Manage and coordinate Quality Control Visits (QCVs), In-house Quality Control Plan (IHQCP), and other Quality Control Checks.
- Perform root-cause-analysis for audit observations/inspection findings, manage and track Corrective and Preventive Actions (CAPAs), and coordinate/facilitate responses to audit/inspection reports.
- Communicate and escalate quality/compliance issues to local country operations management and RCQM.
- Bachelor's Degree or equivalent in a relevant healthcare area.
- A minimum of 6-8 years of relevant experience in clinical research, including direct field monitoring experience or management/oversight of such individuals.
- Deep knowledge and understanding of Clinical Trial processes, Good Clinical Practices, and other clinical research-related regulations.
- Solid track record of initiating, planning, and delivering projects and knowledge of project management practices.
- Demonstrated experience in leading cross-functional teams and managing audits and inspections.
- Excellent oral and written communication and leadership skills in an international environment.
- Ability to analyze, interpret, and solve complex problems, think strategically, objectively, and with creativity and innovation.
As a Clinical Quality Manager at MSD, you will have the opportunity to work with a talented team of professionals, contribute to the delivery of high-quality clinical trials, and develop your skills and expertise in a dynamic and challenging environment.
