Remote Good Clinical Practices (GCP) Auditor

Summary

Join our consultant network and work on a project-by-project contract basis as a GCP Auditor or Operations quality services provider for pharmaceutical and biotechnology clients.

Requirements

• Bachelor’s degree (or higher) in Pharmacy, life sciences, or related discipline
• 10+ years of relevant experience working within the pharmaceutical or biotech industry
• Working knowledge of global GCP requirements including industry quality systems/standards
• Proven experience in set up of Quality oversight procedures and Quality Systems for Clinical trial Operations
• Ability to apply appropriate GCP regulatory knowledge to multiple scenarios
• Minimum 2 years GCP auditing experience; Certified quality auditor is a plus
• Familiarity with GCP computerized systems used in support of Clinical trial execution
• Clinical laboratory auditing experience a plus
• Investigator site auditing experience is a plus
• Experience with set up or auditing of CROs is a plus

Preferred Qualifications

• Demonstrated technical writing & speaking fluency in English
• Advanced regulatory knowledge acquired through experience in the pharma industry or clinical application
• Experience as an independent consultant to Bio/Pharma is a plus
• Ability to work across functional areas, or previous client engagement experience, such as CRO or similar is a plus