Manager, Clinical Quality Assurance

Job Summary

A company is looking for a Manager, Clinical Quality Assurance.

Key Responsibilities

• Provide oversight to global clinical studies ensuring compliance with GCP and regulatory requirements
• Establish and enhance GCP QA programs, policies, and procedures
• Manage internal and external quality audits of clinical vendors and investigator sites

Required Qualifications

• Prior experience in the biotech, pharmaceutical, or CRO industry
• In-depth knowledge of GCP, GLP, ICH, and clinical trial operations
• Experience with GCP audits and/or regulatory inspections
• Bachelor's degree in life sciences or a related field (advanced degree preferred)
• A minimum of 8 years of related experience with a bachelor's degree; or 6 years and a master's degree