Part-Time Laboratory Director - MLM Medical Labs : Job Details

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MLM Medical Labs is global leading specialty and central laboratory with comprehensive research services and analytical capabilities. Offering standard and fully customizable biological specimen testing and auxiliary logistics services across a wide spectrum of therapeutic areas, we add value at every stage of the product development process, from nonclinical and preclinical through phase IV clinical trials. We pride ourselves on our commitment to excellence, regulatory compliance, and innovative solutions that drive scientific progress. We are seeking a part-time Laboratory Director that provides strategic, clinical and regulatory leadership, supporting both scientific integrity and operational excellence to join our dynamic team.

Job Overview

The Laboratory Director is responsible for overseeing all operations of a CAP-accredited and CLIA-certified clinical laboratory located in the state of Tennessee. This part-time role ensures the laboratory maintains full compliance with CAP accreditation, federal CLIA regulations, and Tennessee Department of Health, Division of Health Licensure and Regulation standards. The director provides strategic, clinical, and regulatory leadership, supporting both scientific integrity and operational excellence.

Key Responsibilities

Regulatory Compliance & Licensure

• Ensure compliance with Tennessee-specific laboratory licensure requirements, CAP, and CLIA standards.
• Maintain the laboratory's state licensure and assist with state inspections and audits.
• Oversee validation and verification of test methods in accordance with Tennessee laboratory regulations.
• Ensure compliance with Tennessee Rule Chapter 1200-06-01 regarding laboratory personnel, records, and quality.

Quality & Accreditation

• Lead efforts to maintain CAP accreditation and ensure readiness for biannual inspections.
• Review and sign off on proficiency testing results and ensure timely remediation of deficiencies.
• Oversee the laboratory's Quality Management System (QMS), including review of QC/QA metrics, incident reports, and CAPA plans.
• Monitor laboratory performance indicators and implement continuous improvement initiatives.

Technical & Operational Oversight

• Provide final approval of test methods, including high-complexity assays and instrumentation.
• Ensure clinical validity and appropriateness of the test menu.
• Supervise technical personnel and provide support for troubleshooting, workflow optimization, and training.
• Review and authorize laboratory SOPs and validation reports.
• Ensure all technical staff are properly licensed by the Tennessee Medical Laboratory Board.
• Approve personnel qualifications, ongoing competency assessments, and training programs.
• Serve as a mentor and consultative resource for laboratory supervisors and clinical teams.

Strategic & Clinical Leadership

• Collaborate with executive and scientific leadership on laboratory strategy and service expansion.
• Provide medical/scientific input for clinical and operational decision-making.
• Be accessible for urgent consults, regulatory reviews, or inspection preparation as needed.

Required Qualifications

• MD/DO with current Tennessee medical license or PhD in a laboratory science with appropriate national board certification.
• Must meet CLIA qualifications for high-complexity laboratory director (42 CFR § 493.1443).
• Licensed Laboratory Director in Tennessee or eligible for licensure through the Tennessee Medical Laboratory Board.
• Board certification by one of the following:
• American Board of Pathology (ABP)
• American Board of Medical Microbiology (ABMM)
• American Board of Bioanalysis (ABB)
• National Registry of Certified Chemists (NRCC)
• Or equivalent recognized body
• Minimum 2–3 years of experience overseeing a CAP-accredited laboratory.
• Demonstrated understanding of Tennessee laboratory rules and CAP/CLIA standards.

Schedule & Time Commitment

• Remote work possible, with on-site presence as required for compliance and inspections
• Must be available for annual reviews, inspection preparation, and emergency consults

Preferred Experience

• Familiarity with molecular diagnostics, toxicology, clinical chemistry, or infectious disease testing
• Prior involvement in CAP inspections (team member or hosting lab)
• Experience with laboratory information systems (LIS), QMS tools, and digital compliance platforms

Seniority level

• Seniority levelDirector

Employment type

• Employment typePart-time

Job function

• Job functionResearch, Analyst, and Information Technology

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