Laboratory Director

MainStreet Family Care•Wake Forest, NC

About The Position

Lab Director – Wake Forest, NC MainStreet Family Care operates over 60 fast-growing urgent care clinics across Alabama, Florida, Georgia, and North Carolina. As we continue expanding access to high-quality healthcare in rural communities throughout the Southeastern U.S., our mission remains the same: quality care, close to home. Due to continued growth, we are seeking a Laboratory Director to provide medical and regulatory oversight for our laboratory operations supporting clinics in the Wake Forest, NC area. This role ensures that laboratory testing is performed in compliance with CLIA regulations and applicable quality standards while supporting the delivery of reliable diagnostic results that directly impact patient care. The Laboratory Director provides strategic oversight, quality assurance leadership, and regulatory guidance for laboratory operations performing moderate- and high-complexity testing, including real-time PCR diagnostics. This role serves as the CLIA-designated Laboratory Director and is responsible for ensuring the laboratory maintains regulatory compliance, quality testing standards, and appropriate oversight of testing procedures and personnel. This position does not involve direct management of laboratory staff, hiring, scheduling, or daily operational supervision. The Laboratory Director will provide periodic oversight and consultation and will conduct on-site laboratory reviews approximately once every three months.

Requirements

Must meet CLIA requirements to serve as a Laboratory Director for high-complexity testing, including one of the following qualifications:
Licensed MD or DO with board certification in anatomic pathology, clinical pathology, or hematology
Doctoral degree (PhD, DSc, or equivalent) in a chemical, biological, clinical, or medical laboratory science and certification by an HHS-approved board
Two (2) or more years of experience directing or supervising high-complexity laboratory testing
Strong knowledge of CLIA regulations governing high-complexity laboratory testing
Expertise in laboratory quality assurance and quality control systems
Ability to review and evaluate laboratory testing methodologies and validation procedures
Strong analytical and problem-solving skills
Ability to interpret laboratory data and testing performance metrics
Effective written and verbal communication skills
Ability to provide guidance and oversight across multiple laboratory locations
Comfort working with diagnostic testing processes involving patient specimens

Nice To Haves

Experience serving as a CLIA Laboratory Director
Experience with molecular diagnostic testing, including PCR-based assays
Experience supporting laboratories in urgent care, outpatient, or high-volume clinical environments
Familiarity with COLA or similar laboratory accreditation programs

Responsibilities

Provide CLIA-designated Laboratory Director oversight for laboratory testing operations
Ensure laboratory compliance with CLIA regulations and other applicable regulatory standards
Review and approve laboratory policies, procedures, and testing methodologies
Ensure appropriate systems are in place for pre-analytic, analytic, and post-analytic phases of testing
Provide oversight of quality assurance and quality control programs to ensure accuracy and reliability of laboratory results
Review proficiency testing results and ensure appropriate corrective actions are implemented when necessary
Provide consultation regarding laboratory test results and interpretation as needed
Ensure laboratory testing methodologies are appropriate for patient care and produce reliable results
Review and approve changes to laboratory procedures, policies, and testing protocols prior to implementation
Ensure proper documentation and retention of regulatory and proficiency testing records
Remain accessible to laboratory personnel for consultation by phone or electronic communication as needed
Conduct periodic on-site laboratory reviews approximately once every three months to evaluate compliance, testing practices, and quality processes
Support continuous improvement of laboratory quality systems and diagnostic capabilities