Responsible for managing clinical quality function, ensuring compliance with local clinical trial regulatory requirements and Takeda’s Quality Management Systems
Job Summary
Responsible for managing clinical quality function, ensuring compliance with local clinical trial regulatory requirements and Takeda’s Quality Management Systems.
Drives the development and implementation of CQA procedures and local QMS, establishing and maintaining local risk register, and leading supplier and individual clinical study audits.
Provides GCP guidance to day-to-day questions, participates in review and approval of critical Clinical Study documents, and manages relationships with local regulatory authorities.
Matching Summary
Responsible for managing clinical quality function, ensuring compliance with local clinical trial regulatory requirements and Takeda’s Quality Management Systems.