Senior Manager, GCP Quality Assurance

Job Summary

A company is looking for a Senior Manager, R&D Quality Assurance (Hybrid).

Key Responsibilities

• Lead quality assurance activities for clinical trials and oversee audit processes
• Conduct risk-based reviews of study documents to ensure compliance with regulations
• Drive inspection readiness efforts and manage quality events related to non-compliance

Required Qualifications

• Bachelor's degree in life sciences or a related field (Master's preferred)
• Strong experience in GCP Quality Assurance and late-phase clinical trials
• Proven ability to lead audits and inspection readiness efforts
• Comprehensive knowledge of GCP regulations and industry guidance (e.g., FDA, EMA)
• Familiarity with Quality Assurance functions such as auditing and regulatory affairs