About this role
GCP Operational Quality Senior Manager
General Summary:
The Senior GCP Operational Quality Manager conducts quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Vertex policies and procedures. These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring quality issues and compliance metrics.