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Role Objectives:
- Provide strategic leadership of the GCP Quality Management System for global clinical operations.
- Ensure compliance with ICH GCP, regulatory requirements, and internal standards while fostering a culture of quality.
What You'll Do:
- Manage day-to-day Clinical Quality team activities, including workload planning and performance management.
- Oversee QMS records such as deviations, CAPAs, and risk assessments, and lead Sponsor audits and regulatory inspections.
- Drive continuous improvement and quality governance across clinical operations.
What You'll Need:
- Bachelor's degree in a related field and 5-7 years of Clinical Quality experience.
- Minimum 2-3 years of people leadership experience and strong knowledge of GCP and global regulations.
WEP Clinical
WEP Clinical partners with biopharmaceutical sponsors to bring treatments to patients through clinical trial delivery and home health services. With over 15 years of global experience, the company fosters a collaborative, innovative culture focused on improving patient outcomes.