Global Clinical Quality (GCQ) Associate Director

Job description

Job Description General Summary: The Associate Director of GCP Operational QA performs advanced GCP Quality Assurance oversight and management activities of clinical trial operations and applicable vendors, to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Vertex policies and procedures and quality standards as set forth in the Quality Management System. 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 and trending of quality risks, issues and compliance metrics, investigation and CAPA management and proactive inspection readiness activities. Key Duties and Responsibilities: - Serve as a key technical resource for the GCP clinical execution function with responsibility of assuring quality risk management/ mitigation and adequacy and compliance with GCP regulatory requirements and guidance to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated - Liaise with clinical functions and...