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
