Auditor, GCP


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


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



contract research organization


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