Research Quality GCP Inspection Lead

Location: Remote
Compensation: Salary
Staff Reviewed: Fri, Mar 29, 2024
This job expires in: 16 days

Job Summary

A company is looking for a Research and Development Quality GCP Inspection Lead.

Key Responsibilities:
  • Develop and implement risk-based Inspection Management processes for Research & Development pipeline
  • Lead Regulatory Authority inspections and manage all phases of inspections
  • Ensure inspection playbooks are updated and collaborate with Inspection teams for continuous improvement

Required Qualifications:
  • Doctorate, Master's, Bachelor's, Associate's degree, or High school diploma with relevant experience
  • Minimum 3 years of experience in pharmaceutical/biotech or medical device industry in quality management
  • Understanding of medical device development, Precision Medicine, and Quality Management Systems
  • Experience with compliance to GxP requirements and oversight of third-party vendors
  • Ability to develop and implement Analytics methods for signal detection and quality improvement

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