Associate Laboratory Director

Job title: Associate Laboratory Director

About the Role The Associate Laboratory Director supports the operation and administration of FMI clinical laboratory site under the direction of the Laboratory Director/CLIA license holder. This role contributes to regulatory compliance, personnel competence, and the accuracy/timeliness of laboratory results to support patient care and business needs. The position partners with site leadership, particularly Laboratory Operations and Quality Assurance, to maintain compliance with CAP, CLIA, NYS, and ISO, and collaborates with the Laboratory Director on regulatory readiness, inspections, corrective actions, and ongoing quality improvement. The Associate Laboratory Director also serves as a molecular and laboratory medicine subject matter expert, providing scientific and clinical input for regulatory submissions and internal product development, and participates in the review of documents, policies, and reports to support testing strategies and assay validation.

What You'll Do

• Provide operation and administration of the FMI clinical laboratory site under the direction/ delegation of the Laboratory Director/CLIA license holder
• In partnership with Lab Operations Site Head, Director of Quality Assurance Lab Operations, QA LabOPs Licensure & Accreditation team, and LDs at other sites, ensure compliance with all applicable laws/regulations (CLIA, NYS, CAP, ISO) and participate in inspections, audits, and self-inspections
• Ensure supervision of testing personnel, reporting of test results, and adherence to FDA requirements where applicable
• Maintain compliance with CAP and ISO 15189 accreditation requirements and terms of accreditation
• Communicate with regulatory/accrediting bodies and respond to information requests in investigations
• Ensure appropriate staffing/resources in collaboration with leadership to sustain quality and safe operations
• Implement and monitor an effective Quality Management System (QMS) and continual improvement activities
• Support assay validation/verification, optimization, proficiency testing, alternative assessment, and QC procedures
• Ensure participation in and compliance with all steps of an HHS-approved proficiency testing program, as applicable
• Ensure remediation and documentation of deviations from performance specifications; report patient results only when systems function properly
• Provide initial and timely review/approval of laboratory documents (validations, SOPs, non-conformances, planned deviations, OQs/IQs, and other technical docs)
• Provide clinical expertise for corporate initiatives on modifying tests or expanding capabilities, including equipment, supplies, and supplier selection/monitoring
• Communicate with FMI CLIA laboratory directors and Pathology/Diagnostic Medicine leadership to ensure testing consistency across sites
• Contribute to leadership team goals, strategy, and tactical planning; coordinate KPIs and resource plans
• Contribute clinical/subspecialty expertise to cross-functional initiatives and diagnostic medicine services; participate in cross-functional projects
• May participate in research studies leading to abstracts, peer-reviewed publications, and presentations

What We're Looking For

• Experience in operation/administration of a clinical diagnostic laboratory under CLIA/licensing requirements
• Strong knowledge of regulatory/accreditation requirements (CAP, CLIA, NYS, ISO) and experience with inspections
• Expertise in assay validation/verification, proficiency testing, and quality control
• Demonstrated leadership, collaboration, and ability to work with site leadership and cross-functional teams
• Molecular and laboratory medicine subject matter expertise
• Ability to review/approve technical documents (SOPs, validations, reports) and support regulatory submissions
• Excellent communication, problem-solving, and project management skills
• Willingness to participate in research activities and scientific/clinical innovation

Compensation & Benefits

• Not specified