Last updated: August 17, 2026

Auditor, GCP

Responsibilities

The GCP Auditor is responsible for quality assurance auditing of all activities subject to the, “ICH Good Clinical Practice: Consolidated Guideline,” (GCPs), supporting a program of quality assurance (QA) to ensure that AGN project data and summary statements are of known and documented quality.

Summary of Responsibilities:

• Audit of Activities and Vendors Subject to GCP regulations
• With manager oversight, liaise with Business Customers and Compliance Partners to Support the Identification & Mitigation of Risk within AGN R&D/MA (Pharma and Med Devices)
• Interface with Quality & Compliance Functions
• Interface with Regulatory Agencies

Requirements

Education and Experience

• Bachelors degree required
• Scientific training and advanced degree are desirable
• GCP knowledge gained through 1-5 years GCP audit experience
• Scientific background with demonstrated hands on knowledge of the clinical environment with specific experience in 1) a drug development role or a 2) regulatory agency inspector role.
• Basic knowledge of worldwide regulatory requirements and/or pharmaceutical development practices.
• Knowledge/understanding of the approach and perspectives of regulatory agencies.

Essential Skills and Abilities

• Good written and verbal communication skills, demonstrated ability to function strategically and effectively with all levels of management
• Strong negotiation and relationship building skills
• High degree of organizational awareness

Scientific Case Review

Would you like to understand whether current clinical programs, recent research developments, or emerging approaches may be relevant to your individual situation?

Share your question with our scientific research team and receive information focused on the areas of current research that may be relevant to your case.

• Review of the information you provide
• Relevant research and clinical program information
• A clear response focused on your situation

What happens next? Send your question, receive a focused scientific review, and get a clear response about research and clinical programs relevant to your situation.

Your scientific review will be prepared by Dr. Helen Melnik, PhD , who has more than 25 years of experience in stem cell research and international clinical programs.

☎ WhatsApp Request My Personal Scientific Review ✉ Email Request My Personal Scientific Review

No obligation. Your question will be reviewed confidentially.

Educational and research information only. This service does not constitute medical advice, diagnosis, prescription, or a personalized treatment recommendation.