Regulatory Compliance Expert
hace 4 días
This role requires a strong understanding of Quality Management methods, systems, and relevant procedures.
The Regulatory Compliance Expert will support the development and implementation of initiatives and established processes that support operations in maintaining inspection readiness.
The role will also involve collaborating with QA to identify quality issues and plan of action, including support for creation of deviations and development of effective CAPA.
- Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials
- Ability to lead and execute continuous improvement
- Experience in inspection preparation, participation, and follow-up
Responsibilities
- Works with Study Team leadership (and QA, as needed) to identify quality issues and plan of action, including support for creation of deviations and development of effective CAPA
- Sits across the entire global portfolio or a particular asset(s)
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