Research Quality GCP Inspection Lead

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