Reporting to top management on the effectiveness of the Quality Management System. Recommending and implement system improvements. Ensuring the Quality Management System meets the requirements of ISO 9001 and other requirements as required by contract. Managing the processes for internal and external audit and corrective and preventive action.
Manage quality issues including audit reports, quality issues/incidents, and CAPA development, working closely with RDQ audit team and clinical development. Ensure timely implementation and closure of CAPAs.