Associate Director, GCP Quality (Remote Position)
A cutting-edge biotech is seeking an expert in GCP Compliance to join their growing QA team. This role can be operated from anywhere in the United States.
Essential Functions
- Oversee clinical quality management and providing support to clinical trials teams
- Proactively manage quality for clinical trials, ensure adequate vendor oversight and address any quality issues
- Support cross-functional colleagues in the development of responses for internal system audits and regulatory inspections
- Work with cross-functional teams to develop, prioritize and implement quality plans based
- Participate in and/or lead forums and process improvement/system initiatives related to critical quality processes
Requirements
- Bachelor's Degree in relevant health care area
- Minimum 8 years in the pharmaceutical or biotech industry experience and at least 5 years of direct experience in GCP auditing and inspections OR in Clinical Development or Operations managing or supporting clinical trials.
