Temporary CLIA Laboratory Quality Manager

About the role

This temporary role will support laboratory preparation and CLIA certification while overseeing quality control and quality assurance processes, regulatory compliance, operational readiness, and laboratory documentation and reporting. These responsibilities are critical to ensuring compliance with CLIA regulations and institutional standards while supporting the laboratory's successful implementation and ongoing operations.

Minimum Qualifications

• Bachelor's degree in healthcare administration, business, law or closely related field
• Ten years of experience in healthcare, hospital and/or academic medicine
• Any equivalent combination of education, experience and training

Knowledge, Skills and Abilities

• Senior Leadership Skills
• Communication Skills
• Start up and built from scratch lab environment experience
• Strong Documentation Skills

Preferred Qualifications

• Bachelor's degree in Medical Laboratory Science, Biology, Chemistry, or related field (Master's preferred)
• ASCP certification (MT, MLS, or equivalent) and CAP accreditation strongly preferred
• 5–8 years of laboratory experience, with at least 2 years in a QC/QA or compliance focused role
• Direct experience with CLIA regulations and lab certification processes

Responsibilities

• Design and implement all QMS policies, procedures, and daily checks
• Investigate any errors, failures, or unexpected results and document corrective actions and preventative actions
• Flag risks early, ensure every test meets federal and state regulations, proper documentation and response to all internal and external audits and report QC metrics and compliance status to leadership on a regular basis
• Maintain QC and QA records that are audit-ready at all times, all regulatory requirements - CLIA, CAP, HIPAA, and applicable local and state regulations, build and maintain the QMS and Standard Operating Procedures (SOP)
• Lead the lab through the CLIA certification process from application to approval (Essential)
• Serve as the primary point of contact for inspections (CLIA, CAP, state, federal) (Essential)
• Manage proficiency testing programs and ensure timely submission
• Oversee daily lab workflows to ensure efficiency and accuracy
• Monitor incidents/deviations, calibration records, maintenance logs, and vendor relationships, internal audits and continual quality improvement, environmental conditions, and reagent and supply inventory from a QA/QC perspective