CLIA Laboratory and Medical Director

Job Title:

CLIA Laboratory and Medical Director

Job Number: 36809

Location: Morrisville, NC

The CLIA Laboratory and Medical Director will oversee the delivery of high-quality clinical laboratory services and will be listed as the CLIA Laboratory Director on the laboratory license. Core responsibilities include histology slide review, tissue selection, interpretation and sign-out of molecular assays, assay development and validation, participation in overall laboratory operations, and advancing digital pathology capabilities.

• Manage operations of the histopathology laboratory in compliance with CLIA, CAP, NYS, and all other relevant regulations.
• Review histology slides to estimate tumor content, correlate findings with diagnoses, and consult with referring pathologists and oncologists when discrepancies are identified.
• Actively participate in the quality management system, including oversight of adverse outcomes, non-conformities, proficiency testing, and on-site survey participation, along with the implementation of corrective actions as needed.
• Oversee the laboratory’s quality management program to ensure adherence to the standards outlined in the Clinical Laboratory Practice Standards.
• Provide continuing education and training to technical staff, ensuring content is relevant to laboratory medicine.
• Establish and maintain policies and procedures for staff competency monitoring; provide remedial training or continuing education as necessary.
• Promote and maintain a safe working environment for laboratory personnel and the public.
• Ensure that all staff have access to an up-to-date, approved procedure manual.
• Monitor laboratory work to confirm the generation of accurate, medically reliable results.
• Ensure the laboratory regularly evaluates and monitors the quality and appropriateness of services provided, regardless of where testing is conducted.
• Advise referring physicians on the clinical significance of laboratory findings and ensure test reports include all information needed for appropriate patient interpretation.
• Implement corrective action plans for identified deficiencies promptly and effectively.
• Report any concerns regarding test quality or safety to the Supervisor or Safety Officer.
• Review and approve laboratory documentation, including policies, procedures, validation plans, training and competency assessments, quality audits, deviation approvals, reagent/instrument qualifications, and reports of nonconforming events.

• Licensed physician in North Carolina (or eligible for state licensure).
• Formal training and proven expertise in histopathology within the last six years, using accepted and current methods and techniques in one or more of the required categories.
• Certification by the American Board of Pathology in both Anatomic Pathology and Clinical Pathology, ideally with additional specialization relevant to molecular genetics.
• Eligible for or currently holding New York State qualifications in Oncology and Histopathology.
• Board certification in Molecular Genetic Pathology (or equivalent credentials) is highly desirable.

• Competitive salary package along with comprehensive company-wide benefits.
• Clear opportunities for career growth and ongoing professional development.
• A supportive, innovative, and collaborative workplace focused on advancing cancer care and improving patient outcomes.