CLIA Laboratory Manager - Anatomic Pathology

Key Responsibilities

• Operational Leadership: Manage day-to-day operations, including workflow, staffing schedules, and resource allocation to ensure efficiency and timely delivery of service to our customers.
• Regulatory Compliance: Ensure full compliance with all federal and state (CLIA-CDPH-LFS) regulations and accreditation standards (e.g., CAP, NYSDOH). Maintain current laboratory licenses and certifications, collaborate with Quality Assurance support for handling renewals and changes as needed. Prepare the laboratory for inspections and audits by regulatory bodies.
• Quality Assurance & Control: Develop, implement, and maintain quality management systems and standard operating procedures (SOPs). Oversee quality control programs, proficiency testing & performance, and implement corrective actions when deviations occur. Analyze test result data, prepare performance reports, and lead continuous quality improvement initiatives.
• Personnel Management: Supervise, hire, train, and mentor laboratory staff (Clinical Laboratory Scientists, Lab Assistants, Histotechnologists, etc.). Conduct annual performance and competency evaluations, ensuring all personnel are appropriately trained and documented before testing Clinical-Trial specimens. Foster a collaborative and safe work environment, enforcing all safety protocols and addressing potential hazards immediately.

Qualifications

• Bachelor of Science degree in Medical Technology, clinical/medical laboratory science, biological science, related life science field, or equivalent from an accredited institution AND 4+ years working in a high complexity testing laboratory with a doctoral level Laboratory Director.
• OR Master’s degree in medical technology, clinical laboratory science, chemical, physical, or biological science AND 4+ years working in a a high complexity testing clinical laboratory with a doctoral level Laboratory Director.
• OR PhD degree in medical technology, clinical laboratory science, chemical, physical or biological science AND 2+ years working in a high complexity testing clinical laboratory with a doctoral level Laboratory Director.
• Possess a current California laboratory technologist license (CLS generalist).
• 3+ years of people leadership experience with accountability for clinical laboratory direct reports.
• High complexity clinical laboratory experience, with knowledge of anatomic pathology, histological techniques, and Immunohistochemistry.
• Experience in clinical document writing for laboratory SOP’s and validations.
• Clinical-Trial testing and reporting experience.
• Willing to be hands on.

Preferred Qualifications

• Basic understanding of companion diagnostics and drug development.
• Practical experience with anatomic pathology and immunohistochemistry.
• Validation of LDT’s for companion diagnostics testing for Clinical-Trials.
• Experience with other diagnostic modalities such as in situ hybridization and flow cytometry.
• HTL/HT (ASCP) Certification.
• Knowledge or experience with lab automation, including implementation of a Laboratory Information Management System.