Manager, Molecular Diagnostics Laboratories

The University of Kansas Health System•Kansas City, KS

About The Position

This position provides operational leadership for the Molecular Diagnostics Division at The University of Kansas Health System. The Manager is responsible for regulatory compliance and overall laboratory performance, ensuring accurate, timely, high-quality patient testing and compliance with applicable regulatory and accreditation requirements. The role oversees staffing, scheduling, training, competency assessment, budgeting, quality assurance and improvement, and departmental operations. It also leads operational, financial, and personnel functions, including customer service, contracting, billing, coding, inventory, equipment, and human resources. The Manager oversees inspections, audits, accreditation, and external laboratory assessments, and promotes a patient-centered culture of collaboration, accountability, and continuous improvement. The role supports the Health System’s mission, vision, values, and strategic initiatives through resource management, sound decision-making, and communication, and aligns departmental goals with organizational priorities. The Manager works with section Directors and Division Leadership to plan for current and future molecular diagnostics needs. In collaboration with the Medical Director and Section Director, the Manager ensures sound development and validation practices and confirms and documents test performance characteristics. The role maintains appropriate quality-control systems, resolves technical problems, ensures corrective actions are completed before results are reported, and supports proficiency testing and MolDx Technical Assessment submissions. It also leads personnel management, training, competency evaluation, record review, and communication with regulatory and accrediting agencies. The position is based at Bell Hospital, Strawberry Hill Campus.

Requirements

Bachelor of Science in Chemistry, Biology, Medical Lab Science, or Physics from an accredited college or university.
At least 2 years of supervisory experience in a high-complexity PCR and NGS molecular laboratory.
At least 5 years as an ASCP-certified Medical Lab Scientist or Molecular Scientist (MB), with PCR and NGS experience.
Upon hire, hold either Medical Laboratory Scientist (MLS) certification from the ASCP Board of Certification or Technologist in Molecular Biology (MB) certification from the ASCP Board of Certification.
Fluent English.

Responsibilities

Partner with section Directors and Division Leadership to establish strategy for current and future molecular diagnostics needs.
Work with the Medical Director and Section Director to ensure test development and validation practices meet or exceed regulatory requirements.
Ensure test performance characteristics, including sensitivity, specificity, and accuracy, are confirmed and documented.
Provide internal and external consultation as needed and as required by CLIA.
Ensure enrollment and participation in a CAP-approved proficiency testing program appropriate to services offered.
Submit MolDx Technical Assessments in a timely manner and support successful outcomes for z code claims and reimbursement.
Establish and maintain quality-control programs and acceptable analytic performance across the testing process, from specimen receipt through analysis and reporting.
Resolve technical problems and ensure remedial actions are taken when test systems deviate from established performance specifications.
Manage human-resource functions, including interviewing, selection, orientation, education and training, feedback, performance evaluation, and policy and procedure development.
Maintain personnel files documenting orientation, competency, training, discipline, and performance reviews.
Oversee department timekeeping and payroll; manage employee issues and performance, including coaching, counseling, discipline, and annual appraisals.
Monitor staff adherence to hospital and departmental policies and procedures.
Provide technical consultation on policies, procedures, and practices.
Ensure patient test results are not reported until corrective actions are complete and the test system is functioning properly.
Identify training needs and ensure testing personnel receive regular, appropriate in-service training and education.
Evaluate testing personnel competency and ensure staff can perform procedures and report results promptly, accurately, and proficiently.
Provide effective team leadership and identify and communicate critical success factors.
Report to regulatory and accrediting agencies as appropriate.
Review ongoing records concerning reagent and control reactivity, instrument function checks, and temperature records.
Delegate duties as appropriate, including general supervisor and testing-personnel roles specified in laboratory policies.
Perform the professional, clinical, or technical competencies of the assigned unit or department.