Lighthouse Lab Services is thrilled to be partnering with a clinical diagnostics laboratory located just outside of Paris, France, to recruit a PART-TIME REMOTE Laboratory Director & Clinical Consultant in Immunology. This is a unique opportunity: you will reside in the U.S. while ensuring that the laboratory, located in France, meets all CLIA International and CAP regulatory requirements.
Key Responsibilities
- Serve as the U.S. CLIA Laboratory Director, ensuring full compliance with CLIA (and CAP) regulations
- Act as Clinical Consultant in immunology: approve, interpret, and guide assay development, validation, troubleshooting, and result interpretation
- Oversee QC/QA, method validation, proficiency testing, corrective actions, and audit readiness
- Maintain staff competency, training, and requisite documentation
- Prepare and maintain regulatory documentation, lead inspections, and manage responses to findings
- Monitor performance metrics, risk management, continuous improvement initiatives
- Provide ~6 hours/month remote oversight and lead biannual on-site audits in Paris
- Advise on instrumentation, reagents, assay upgrades, technical strategy
- Interface with French/local laboratory staff on operations, quality, and compliance
- Engage in budget planning, resource allocation, and strategic leadership
- Travel logistics and coordination for on-site visits
Required Qualifications & Experience
Regulatory / Director Credentials
- Must satisfy U.S. CLIA requirements to act as Lab Director for high complexity immunology testing
- Eligible credentials include: A MD or DO licensed to practice in any state in the US and holds a board certification from the American Board of Pathology or the American Osteopathic Board of Pathology ORPhD in a biological science with board certification (e.g., ABB, ABMLI, DMLI). For more information on these board certifications, please access this link -https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/certficiation-boards
- Strong track record with CAP accreditation, inspections, and corrective actions
- Deep familiarity with U.S. federal regulatory requirements (42 CFR Part 493), documentation, inspections, audit preparedness
- Prior experience in a CLIA/CAP laboratory director or consultant role
- Demonstrated ability to work across international regulatory / operational settings is strongly preferred
Technical / Scientific Expertise
- Expert in immunology assays (e.g. flow cytometry, ELISA, multiplex
- PCR experience required: demonstrated expertise with PCR-based testing (qPCR, RT-PCR, or digital PCR) for diagnostic and research applications, including validation and troubleshooting immunoassays, cytokine panels)
- Experience with method development, validation, troubleshooting, assay performance evaluation
- Good statistical knowledge of QC/QA, measurement uncertainty, proficiency testing, control charts
- Knowledge of laboratory information systems (LIS), data integrity, interoperability, reporting
Leadership / Management
- Excellent communication skills, able to bridge U.S. and French teams, and interact with stakeholders and regulators
- Proven ability to lead remote teams, mentor, delegate, and oversee from a distance
- Previous experience in roles combining remote oversight with occasional on-site presence (especially internationally) is highly desirable
- Willingness to travel internationally, manage logistics, and operate across time zones
Preferred Candidate Profile
- Prior experience overseeing U.S. regulatory oversight for a laboratory located outside the U.S.
- Experience integrating practices across different national regulatory environments
Logistics & Compensation
- Time Commitment: ~6 hours/month remote oversight + biannual visits
- Travel & Expenses: All travel, lodging, visa, local costs for Paris visits covered
- Compensation:Competitive compensation based on experience.
- Start Date: Start of 2026
- Preferred U.S. Location: East Coast candidates encouraged (for more favorable time overlap with Paris)
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 22 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.
It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.
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