Laboratory Director

The Laboratory Director provides strategic leadership and operational oversight for laboratory services, ensuring the delivery of accurate, reliable, and high-quality testing while maintaining compliance with applicable regulatory and accreditation standards. This role oversees laboratory management, staffing, quality assurance, technical performance, safety, and resource allocation to support operational excellence and patient safety.

Responsibilities

Provide strategic direction and overall leadership for laboratory operations, including the supervision and development of Laboratory Managers.Oversee staffing, productivity, service levels, departmental resources, and operational performance to ensure efficient and effective laboratory services.Establish, implement, and maintain policies, procedures, and operational standards that promote consistency, accountability, and alignment with organizational objectives.Monitor key performance indicators and identify opportunities to improve efficiency, testing accuracy, turnaround times, service quality, and overall operational effectiveness.Ensure appropriate staffing levels, personnel qualifications, and workforce planning to meet current operational demands and anticipated growth.Mentor and develop laboratory management, technical personnel, and non-technical staff, fostering a culture of leadership, collaboration, and accountability.Ensure laboratory policies, procedures, and established best practices are consistently implemented across all applicable operations.Partner with organizational leadership to evaluate operational needs, prioritize initiatives, and support strategic planning and business objectives.Ensure laboratory operations comply with applicable CLIA, College of American Pathologists (CAP), OSHA, state, and other relevant regulatory and accreditation requirements.Maintain continuous inspection readiness for CAP accreditation inspections, internal audits, self-inspections, mock inspections, and targeted department-, process-, or site-specific reviews.Oversee personnel competency assessments, required training, licensure, certifications, and other applicable regulatory qualifications.Lead or oversee the annual evaluation of laboratory quality and safety programs, ensuring identified opportunities are addressed through appropriate action plans.Ensure timely investigation, documentation, and resolution of audit findings, regulatory deficiencies, quality incidents, and compliance concerns.Oversee the evaluation and interpretation of laboratory data related to instrumentation, analytical processes, quality control, correlation studies, analytical measurement range (AMR) verification, and acceptable performance criteria.Ensure analytical methods, testing processes, and laboratory instrumentation meet established standards for accuracy, precision, reliability, and regulatory compliance.Review quality and performance data to identify trends, potential risks, and areas requiring corrective action or process improvement.Provide oversight of laboratory safety programs and practices in accordance with applicable OSHA requirements, CAP standards, regulatory guidelines, and organizational policies.Ensure appropriate safety protocols, risk mitigation measures, and incident response procedures are established and consistently followed.Oversee laboratory emergency preparedness, disaster response planning, and business continuity procedures to minimize operational disruptions.Identify potential operational, safety, and compliance risks and implement strategies to mitigate their impact on laboratory services.

Qualifications

PhD, Master's degree, or other applicable advanced degree with a clinical laboratory focus or equivalent education appropriate to the position.Minimum of six (6) years of supervisory and/or management experience within a clinical laboratory environment.Strong working knowledge of CLIA, CAP, state regulations, laboratory quality standards, and accreditation requirementsExperience evaluating laboratory quality metrics, analytical performance, and operational performance