Lead Clinical QA Analyst

Job Summary

A company is looking for a Lead Clinical QA Analyst to support quality assurance in clinical research.

Key Responsibilities

• Lead and support Research Quality activities to ensure compliance with relevant regulations and guidelines
• Collect, analyze, and report quality-related metrics, including audit findings and compliance indicators
• Oversee root cause analysis and ensure corrective actions are implemented for quality-related issues

Qualifications & Skills

• Bachelor's degree in Science, Engineering, Life Sciences, Clinical Research, Quality Assurance, or related field; advanced degree preferred
• Deep knowledge of FDA guidelines, ICH-GCP principles, and regulatory requirements
• Proven leadership in quality processes and risk-based methodologies
• Extensive experience in clinical research QA and regulatory compliance (10+ years)
• Technical proficiency in clinical trial management systems and electronic data capture