GCP Quality Assurance Advisor

Job Summary

A company is looking for an Advisor / Sr. Advisor - Good Clinical Practices - Quality Assurance.

Key Responsibilities

• Ensure GCP systems are adequate and executed properly for ExploR&D
• Conduct GCP audits and assessments of clinical third-party vendors and make recommendations
• Monitor changes to GCP regulations and provide quality consultation to cross-functional teams

Required Qualifications

• Bachelor's degree in a science-related field from an accredited institution
• 5+ years of experience auditing GCP third parties, including CROs and clinical sites
• Thorough understanding of early phase clinical research (Ph 1-Ph 2a)
• Experience with GMP and GLP regulations is desirable
• Ability to influence internal and external partners to maintain a quality-focused culture