CLIA Laboratory Director (m/f/d)
Your Responsibilities
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Act as part-time/consultant Laboratory Director for ProtaGene ’s two CLIA-certified high-complexity laboratories in Burlington, Massachusetts, USA and Heidelberg, Germany, in accordance with 42 CFR §§493.1441 and 493.1445.
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Ensure both laboratories operate in compliance with applicable CLIA, CAP, and relevant state requirements, including Massachusetts, California, and Pennsylvania requirements; New York State qualification considered an asset.
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Review and approve relevant test methods, validation activities, procedures, report formats, and major changes affecting clinical testing.
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Oversee the suitability, training, competency, and delegated responsibilities of laboratory personnel involved in high-complexity testing.
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Conduct a minimum of two on-site oversight visits per calendar year to each laboratory location (Burlington and Heidelberg), with travel costs covered separately.
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Review quality-control, proficiency testing/alternative assessment, and performance data; ensure appropriate action is taken where issues are identified.
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Provide scientific and clinical consultation on complex technical, quality, reporting, or compliance matters.
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Support regulatory inspections, CAP/CLIA activities, licence applications, and customer audits as needed.
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Participate in scheduled oversight meetings and site visits, and remain available for significant quality, regulatory, or patient-impact events.
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Maintain appropriate documentation of oversight, reviews, decisions, and delegated responsibilities.
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Contribute to and comply with corporate safety, environmental, and quality standards.
Note: The Laboratory Director retains independent professional authority and accountability for the quality, reliability, and regulatory compliance of testing performed under each laboratory’s CLIA certificate.
Note: While the ideal candidate shall be available for both ProtaGene laboratories, those capable of holding only one of the two sites may also be considered.
Requirements
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Eligible to serve as Clinical Laboratory Director for two CLIA-certified laboratories performing high-complexity testing, in accordance with 42 CFR §493.1443, 105 CMR 180.060, and any applicable requirements for California and Pennsylvania laboratory licensure.
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Meet the applicable Massachusetts and CLIA director-qualification pathway, including either:
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MD or DO licensed to practise in Massachusetts and board-certified in anatomic and/or clinical pathology; or
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Earned doctoral degree in a chemical, biological, clinical, or medical laboratory science, medical technology, molecular biology, genetics, genomics, or a closely related discipline, together with certification by an HHS-approved and Massachusetts-acceptable specialty board.
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For non-physician candidates, at least two years of laboratory training and/or experience and at least two years’ experience directing or supervising high-complexity testing in the relevant specialty.
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Board certification in clinical molecular genetics/genomics or a directly relevant specialty is required or strongly preferred, depending on the candidate’s CLIA qualification pathway (e.g., ABMGG or another HHS-approved board).
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Demonstrated experience in clinical molecular diagnostics, genomics, NGS and/or other high-complexity genetic testing relevant to the laboratory’s test menu.
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Strong working knowledge of CLIA, CAP accreditation, Massachusetts clinical laboratory requirements, method validation/ verification, proficiency testing or alternative assessment, personnel competency, quality control, and clinical reporting.
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Ability to meet additional laboratory-director, technical-director, or state qualification requirements for jurisdictions in which the laboratory holds, or intends to obtain, licences or permits. A minimum of California and Pennsylvania is required.
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Integrity, commitment, and a motivated work ethic.
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Ability to work in a team and indepen