Job Summary
A clinical research organization is seeking a Remote Inspections Quality Assurance Director.
Core Responsibilities of this position include:
- Leading company’s Inspection Readiness and Management Team for the preparation, conduct and response to GCP Regulatory Inspections
- Leading the reporting of trends and metrics from all inspection readiness and management activities across the company to aide effective process improvement and risk identification and mitigation
- Establishing strong working relationships with functional leaders and QA colleagues
Qualifications for this position include:
- Ability to travel 10-20%
- An undergraduate degree or its international equivalent in health sciences, auditing etc. from an accredited institution
- More than 15 years industry experience
- More than 10 years QA experience
- More than 10 years managerial experience
- Extensive experience with operational and system auditing, compliance, and SOP development
