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Clinical Quality Operations Manager - Remote
Company Name: Merck
Job Overview
The Clinical Quality Operations Manager is responsible for executing operational quality activities within assigned therapeutic areas, including quality management and inspection management. This role involves overseeing clinical quality operations, supporting trial teams, ensuring vendor oversight, and developing quality plans with a risk-based approach.
Key Responsibilities
- Maintaining inspection readiness
- Managing regulatory inspections
Requirements
- Minimum of 6 years in clinical research (2+ in quality systems/inspections)
- Expert knowledge of GCP/ICH, CAPA, and risk management
- Strong communication and leadership skills