Global Gcp Compliance Quality Assurance Manager
The purpose of the role is to ensure compliance with the activities and processes of the Clinical Research and Development function to Good Clinical Practices (GCP), quality procedural documents, legislation, and applicable guidelines.
In addition, the purpose of the role includes interactions with all personnel at Corporate Drug Development to provide support in the further development and implementation of the Corporate Quality System within the Group.
Main Responsibilities: Ensure the implementation and management of the Clinical Research and Development Quality System's activities in compliance with current applicable legislation and guidelines. Interact with the Quality Assurance (QA) responsible for other business quality systems and with the business units directly or indirectly involved in conducting clinical research activities and processes. Ensure the availability of up-to-date quality procedural documents for the development, implementation, and management of the Quality system for Clinical Research and Development, in compliance with current applicable legislation and guidelines, through the electronic Document Management System (eDMS), when applicable.
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