We are seeking an experienced and highly qualified laboratory leader to oversee our Next-Generation Sequencing (NGS) laboratory operations. This role is responsible for managing laboratory operations, equipment and reagent oversight, regulatory compliance, and serving as a CLIA Technical Supervisor under a high-complexity testing environment. The successful candidate will act as a delegate of the CLIA Laboratory Director and must hold an active Clinical Laboratory Scientist (CLS) license. This individual will ensure operational excellence, regulatory compliance, and the integrity of clinical testing and reporting processes.
KEY RESPONSIBILITIES1. CLIA Technical Supervision (High-Complexity Testing)
- Serve as CLIA Technical Supervisorin accordance with42 CFR 493 requirements.
- Act as delegate of the CLIA Laboratory Director as assigned.
- Review, verify, and approve test records, quality control, and patient test results.
- Ensure test systems are properlyvalidated, verified, andmaintained.
- Overseepersonnelcompetency assessments and technical training.
- Ensureappropriate correctiveactions are implemented for test system failures and non-conformances.
- Participate in inspections (CLIA, CAP if applicable, state, client audits) and regulatory responses.
2. NGS Laboratory Operations Management
- Lead daily laboratory operations including sample processing, library preparation, sequencing, and post-analytical review.
- Oversee equipment lifecycle management (IQ/OQ/PQ, calibration, maintenance, service contracts).
- Ensure reagent qualification, inventory control, lot-to-lot verification, and supply chain continuity.
- Establish operational metrics (TAT, productivity, error rates) and drive continuous improvement.
- Develop andmaintainSOPs in alignment withGxPand quality management system requirements.
3. Quality & Regulatory Compliance
- Ensure compliance with:
- CLIA (high-complexity testing)
- Applicable state laboratory regulations
- GxPrequirements
- ISO 13485 Quality Management System
- IVDR requirements (as applicable)
- Lead internal audits and support external regulatory inspections.
- Manage deviations, CAPA, change controls, and risk assessments.
- Ensuredocumentationintegrity and data traceability.
4. Personnel Leadership & Development
- Supervise laboratory scientists and technical staff.
- Conduct hiring, onboarding, performance management, and competency assessments.
- Foster a culture of quality, accountability, and continuous improvement.
- Ensureappropriate staffinglevels and training coverage.
5. Technical & Clinical Oversight
- Perform clinical testing as needed.
- Review and approve testing records and clinical reports.
- Support assay validation, verification, and new test implementation.
- Collaborate with bioinformatics and R&D teams to transition assays into the clinical environment.
QUALIFICATIONSRequired:
- Active Clinical Laboratory Scientist (CLS) license (State of California preferred if applicable).
- Meets CLIA requirements for Technical Supervisor of high-complexity testing (42 CFR 493.1449).
- Bachelor’s degree or higher in Medical Technology, Clinical Laboratory Science, Molecular Biology, or related field.
- Minimum7+ years of clinical laboratory experience, including NGS or molecular diagnostics.
- Minimum 3–5 years of laboratory management or supervisory experience.
- Direct experience in CLIA-regulated high-complexity laboratoryenvironment.
- Demonstrated experience reviewing and approving clinical test records.
Preferred:
- Advanced degree (MS,MDor PhD).
- Experience with oncology NGS testing.
- Experience in laboratoriesoperatingunder ISO 13485 and/or IVDR.
- Experience supporting regulatory inspections and client audits.
- Lean/Six Sigma or operational excellence experience.
Technical Skills
- Strong understanding of NGS workflows and instrumentation.
- Experience with laboratory equipment validation and maintenance programs.
- Proficiencyin laboratory information systems (LIS) and documentation control systems.
- Strong knowledge of quality systems (CAPA, change control, deviation management).
- Ability to interpret and apply regulatory requirements.
Leadership Competencies
- Strong decision-making and accountability.
- Excellent documentation discipline and attention to detail.
- Clear and effective communication skills.
- Ability to balance regulatory rigor with operational efficiency.
- High integrity and quality mindset.
REPORTING STRUCTURE
- Reports to: CLIA Laboratory Director / Executive Leadership
- Supervises: Laboratory Scientists, CLS staff, Technical Personnel
WORK ENVIRONMENT
- High-complexity clinical molecular laboratory setting.
- May require extended standing, use of PPE, and handling of biological specimens.
