Senior Clinical Quality Assurance Associate

Job Summary

Providing quality leadership to global clinical operations, the full-time Senior Clinical Quality Assurance Associate will oversee GCP quality systems, ensure compliance with regulatory requirements, and manage quality investigations and CAPAs in a remote environment.

Key responsibilities

• Serve as the subject matter expert for GCP quality systems across clinical operations
• Lead investigations for non-conformances, protocol deviations, and compliance issues
• Oversee decentralized clinical trial activities and support audits and inspections

Required qualifications

• Bachelor's Degree or higher in pharmaceutical, life sciences, or engineering
• 3 to 5 years of experience in a quality-related role within a CRO or healthcare organization
• Experience with global clinical trials and decentralized clinical trial activities
• Practical experience with quality investigations, CAPAs, and risk assessments
• Strong understanding of GCP regulations and Quality Management Systems