Lead Clinical Lab QA Specialist
Core
Lead the development, implementation, and maintenance of the Quality Management System (QMS) for Exact Sciences Laboratories, ensuring compliance with clinical laboratory regulatory requirements.
Role type
Senior IC Clinical Lab QA Specialist
Builds
Quality Management Systems and regulatory compliance frameworks for cancer diagnostic laboratories
Domain
Healthcare diagnostics / Clinical Laboratory
Required skills
Quality Management Systems (QMS) management, Regulatory compliance (FDA, CLIA, CAP, HIPAA), Project management, Root cause analysis, Process improvement, Data analysis, Cross-functional collaboration
Preferred skills
Advanced degree in science, State regulatory knowledge (CA, NY, MD, FL), Audit/inspection experience, Six Sigma or PMP certification, KPI/dashboard development, Nonconformance investigation
Technologies
Epic, Microsoft Office
Responsibilities
Manage complex QA projects and continuous improvement initiatives, Investigate and resolve quality assurance concerns, Lead quality management meetings with senior leadership, Provide subject matter expertise and guidance to lab teams, Maintain and monitor QMS effectiveness
Seniority
Senior, hands-on IC