Quality Manager for High Complexity CLIA Lab

The CLIA (Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and compliance oversight to the Nanobiosym diagnostic testing laboratory. This is a highly specialized role that requires the ability to apply CLIA requirements across the laboratory. This position will lead the quality management program for the CLIA laboratory in accordance with the regulatory standards and the quality management system at Nanobiosym. The CLIA Quality Manager will collaborate with direct and/or delegated authority to ensure the CLIA Quality Management Systems (QMS) are effective and compliant with applicable requirements, provide leadership and guidance re: CLIA and associated regulations, and support the Lab Director and leadership in maintaining audit readiness. This position formally serves additional regulatory roles that are applicable to the multiple CLIA, CAP and other accredited bodies. The position requires extensive cross-functional interaction throughout the organization, strong liaison activities with senior management, as well as with external notified bodies and third parties including CLIA, FDA and other global regulatory authorities.