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