QOL (Quality Oversight Leadership)
- Responsible for quality compliance services to ensure the quality and compliance in accordance with ICH GCP, local GCP, applicable regulations, industry best practice
- Responsible of training initiatives, conduct and assessment within the scope of assigned by the company
- Development, review, revision, and maintenance of manual and work flow.
- Plan and develop quality control(QC) plan.
- Provide feedback to PM, COM, or all aspects of compliance, SOP development, and customer requirements.
- Work closely with project team and clinical operations team.
- Conduct on-site monitoring and visit together with the monitors
서울 - 강남구