We are seeking a hands-on clinical laboratory implementation leader to plan, build, license, certify, and launch a new laboratory supporting the company's oncology and microbiology strategy. Core duties are included below. Job Duties: - 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. Requirements - 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. Benefits - Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed) - 401k 10% 1:1 match - PTO policy. 10 days PTO - Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25 - Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental). - Disability insurance 50% standard employer paid. - Carpool, clean air vehicle, and cell phone reimbursement - Employee rewards and recognition program - Company organized social events - Quarterly sponsored team building activities