Director of Quality - CLIA Compliance

Job Summary

A company is looking for a Director, End-to-End Quality - Diagnostic Testing.

Key Responsibilities

• Design and implement a Quality Management System (QMS) for diagnostic testing covering the entire workflow
• Lead quality oversight of sample lifecycle processes, ensuring compliance and integrity
• Oversee laboratory compliance and support readiness for inspections and audits

Required Qualifications

• Bachelor's degree in a life sciences field; advanced degree preferred
• 8-10+ years of experience in a clinical laboratory or healthcare quality role
• Proven experience in building or managing QMS for diagnostic environments
• Deep understanding of CLIA, CAP, HIPAA, and state lab regulations
• Experience across the full diagnostic lifecycle, including sample collection logistics