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Snr Manager Clinical Compliance

Edison-New Brunswick Metro Area, NJ

Post Date: 03/27/2018 Job ID: JN -032018-21218 Job Type: Clinical
BS or Advanced degree in relevant discipline
  • 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.

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