Laboratory Compliance Manager — CLIA/CAP Quality

Rythm; Omaha (NE); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Flexible work

Equity

Unlimited vacation

401(k)

Home testing access

Job summary

Rythm Health seeks a detail-oriented Laboratory Compliance Manager to drive regulatory compliance and quality management across our clinical laboratory operations. You will help maintain readiness for CLIA, CAP, and NYS CLEP inspections and ensure policies, records, and training meet requirements.

You will collaborate with the Laboratory Director, technical leadership, operations, HR, safety, and IT teams to sustain a culture of quality and continuous improvement.

Qualifications

• Bachelor's degree in medical laboratory science, biology, chemistry, health sciences, quality management, or a related field.
• Experience in a clinical laboratory, healthcare compliance, quality assurance, or regulated healthcare environment.
• Working knowledge of CLIA and CAP requirements and clinical laboratory quality systems.
• Strong organizational, auditing, documentation, and project-management skills.
• Excellent attention to detail and ability to manage multiple deadlines.
• Strong written and verbal communication skills.
• Ability to work collaboratively with laboratory staff, technical leadership, and senior management.
• Proficiency with Microsoft Office and electronic document-management systems.
• Experience supporting CAP-accredited and NYS CLEP-permitted laboratories.
• Familiarity with chemistry, immunoassay, hematology, laboratory information systems, middleware, and automated laboratory workflows.
• Experience with regulatory inspections, proficiency testing, competency documentation, method validation, root-cause analysis, and CAPA.
• Certification in medical laboratory science, quality, compliance, or regulatory affairs is preferred.

Responsibilities

• Support ongoing compliance with CLIA, CAP, NYS CLEP, and other applicable requirements.
• Maintain regulatory licenses, permits, accreditation records, compliance calendars, and renewal deadlines.
• Coordinate inspection readiness, internal audits, mock inspections, document requests, deficiency responses, and corrective-action follow-up.
• Administer document control for policies, SOPs, forms, logs, approvals, revisions, and archived records.
• Audit personnel files for required qualifications, licenses, job descriptions, training, competency assessments, and continuing education.
• Coordinate proficiency testing and alternative performance assessments, including documentation and investigation of unacceptable results.
• Support the laboratory quality management system by monitoring quality indicators, incidents, complaints, nonconformances, and corrective and preventive actions.
• Review validation, verification, instrument correlation, lot-to-lot comparison, and change-control documentation for completeness.
• Audit QC, calibration, maintenance, reagent, temperature, specimen-handling, and result-reporting records.
• Monitor regulatory updates and coordinate required changes to policies, processes, forms, and staff training.
• Prepare compliance dashboards and reports for the Laboratory Director and leadership team.
• Escalate significant compliance, quality, and patient-safety risks promptly.
• Promote a culture of quality, accurate documentation, accountability, and continuous improvement.

Job description

Rythm Health seeks a detail-oriented Laboratory Compliance Manager to drive regulatory compliance and quality management across our clinical laboratory operations. You will help maintain readiness for CLIA, CAP, and NYS CLEP inspections and ensure policies, records, and training meet requirements.

You will collaborate with the Laboratory Director, technical leadership, operations, HR, safety, and IT teams to sustain a culture of quality and continuous improvement.