Clinical Quality Assurance Manager

Support the development and maintenance of the Quality Management System according to ICH GCP, regulatory requirements and advocate for continuous improvement

Identify potential risks in trial management activities, actions and risk minimization strategies

Make sure that systems and processes are in place for data and documentation integrity

Lead or assist in the area of quality audits and inspections, supplier selection and qualification, CAPAs, SOPs authoring, review or approval, as appropriate

Support company approach for staff training by providing or coordinating GCP training