CLIA Lab Operations Leader - Oncology & Microbiology

Yowei Therapeutics; Milpitas (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Life insurance (basic & optional)

Disability insurance 50%

401k 10% 1:1 match

10 days PTO

Company holidays

Carpool / transit reimbursement

Employee rewards & recognition program

Team-building activities

Social events

Job summary

Yowei Therapeutics is seeking a hands-on clinical laboratory implementation leader to plan, build, license, certify, and launch a new laboratory supporting oncology and microbiology strategies. You will drive CLIA readiness, licensing, and qualification across facilities, while establishing a robust quality system and selecting LIS/LIMS solutions.

The role requires coordinating with CMS, state agencies, and accreditation bodies, plus leading cross-functional teams to ensure compliant, efficient

Qualifications

• Bachelor’s degree in clinical laboratory science, medical technology, biology, chemistry, health administration, engineering, or a related field.
• 5+ years of relevant clinical laboratory operations, quality, regulatory, implementation, or leadership experience.
• Working knowledge of CLIA requirements and California clinical-laboratory licensing and personnel requirements.
• Experience with laboratory quality systems, method validation or verification, equipment qualification, personnel competency, proficiency testing, inspections, and CAPA.
• Strong project-management, documentation, risk-assessment, and cross-functional leadership skills.

Responsibilities

• Support build and maintenance of an integrated plan for laboratory design, licensing, CLIA certification, validation, inspection readiness, launch, and stabilization.
• Coordinate facility layout, utilities, biosafety, environmental requirements, equipment selection, installation, qualification, maintenance, calibration, and service coverage.
• Lead preparation of federal CLIA and applicable California registration or licensing materials and coordinate with CMS, CDPH Laboratory Field Services, and any selected accreditation organization.
• Establish the laboratory quality system, including documents, training, competency, specimen handling, validation or verification, QC, proficiency testing, reporting, retention, occurrence management, CAPA, and continuous improvement.
• Ensure assays are implemented under approved validation or verification plans appropriate to intended use, methodology, regulatory status, and complexity.
• Select and implement appropriate LIS/LIMS and operational systems with access controls, audit trails, interfaces, review, downtime, and retention procedures.
• Maintain qualification, training, and competency files.
• Prepare for surveys and inspections and manage deficiency responses and corrective actions through closure.

Skills

Project management

Cross-functional leadership

Documentation

Risk assessment

Regulatory knowledge

Education

Bachelor’s degree in clinical laboratory science / related field

Tools

LIS/LIMS selection

Job description

Yowei Therapeutics is seeking a hands-on clinical laboratory implementation leader to plan, build, license, certify, and launch a new laboratory supporting oncology and microbiology strategies. You will drive CLIA readiness, licensing, and qualification across facilities, while establishing a robust quality system and selecting LIS/LIMS solutions.

The role requires coordinating with CMS, state agencies, and accreditation bodies, plus leading cross-functional teams to ensure compliant, efficient