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
