THE ROLERythm Health is seeking a detail-oriented Laboratory Compliance Manager to support regulatory compliance and quality management across our clinical laboratory operations. This individual will help maintain continuous readiness for CLIA, CAP, and New York State CLEP inspections and ensure that laboratory policies, records, personnel documentation, and quality activities meet applicable requirements.
The Laboratory Compliance Manager will work closely with the Laboratory Director, technical leadership, laboratory operations, human resources, safety, and information technology teams.
WHAT YOU'LL DO- 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.
WHAT WE'RE LOOKING FOR- 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.
WHAT'S IN IT FOR YOU?Rythm Health offers a benefits package which includes:
- Highly competitive base salary.
- Meaningful work that genuinely impacts people's lives.
- Equity: Meaningful equity stake aligned with the scope and seniority of this role.
- Monthly Rythm Health membership with full access to at-home blood testing and personalized health insights.
- Generous vacation policy.
- 401(k).
- The opportunity to help define the future of personalized health.
- High ownership and visibility from day one.
- Small, collaborative, mission-driven team.
- Ability to shape both product and design culture early.
