Snr Manager Clinical Compliance
Edison-New Brunswick Metro Area, NJ
- Minimum of 7 years of work experience in clinical research and/or a GCP-related quality assurance environment
- Experience in Clinical QA Operations including GCP Audits, Operational Processes, and managing HA GCP inspections.
- Lead CQA Activities and e-QMS
- Review and evaluate CAPAs and identify risk mitigation support
- Review Audit Inspection Data and trends
- Interact with Health Authorities on Inspection planning and readiness
- Manage and develop team of supporting clinical compliance staff.