Director of Laboratory Regulatory & Quality

Lighthouse Lab Services is seeking an experienced Director of Laboratory Regulatory & Quality for an established clinical diagnostics organization. This individual will oversee laboratory quality programs, regulatory compliance and accreditation readiness, working closely with laboratory operations and executive leadership.

Our client is an established clinical diagnostics organization specializing in molecular infectious disease testing. The organization serves healthcare providers nationwide, delivering diagnostic testing that supports patient care and treatment decisions. With laboratory operations in multiple states and plans to expand its testing services, the organization is looking for an experienced regulatory and quality leader to oversee compliance and support its laboratory teams.

The Director of Laboratory Regulatory & Quality will lead the organization's Quality Management System (QMS) and oversee regulatory compliance, laboratory credentialing and quality improvement efforts. This position works closely with laboratory leadership to maintain compliance with federal and state requirements and prepare for regulatory inspections.

The Director will also coordinate with internal departments on laboratory licensure, Medicare Administrative Contractor (MAC) technical assessments and required regulatory reporting.

• Oversee compliance with CLIA, CAP, CMS, OSHA and applicable state regulations, including New York and California.
• Lead regulatory inspections, surveys, audits and follow-up activities.
• Develop and submit technical assessments and supporting studies required by Medicare Administrative Contractors (MACs).
• Manage required state positivity and CDC reporting.
• Work with revenue cycle management on state laboratory licensure, enrollment and regulatory submissions.
• Monitor regulatory changes and update laboratory policies and procedures as needed.
• Serve as the primary contact for regulatory agencies and accrediting organizations.

• Oversee the organization's Quality Management System, including quality assurance and document control.
• Conduct internal audits, risk assessments and investigations involving quality concerns or nonconformances.
• Manage root cause investigations and corrective and preventive action (CAPA) processes.
• Track quality indicators, nonconformances and corrective action effectiveness.
• Review laboratory workflows and recommend improvements to address compliance concerns.
• Maintain quality documentation and reporting required for inspections and accreditation.

• Oversee personnel credentialing, licensure, certification and renewal processes.
• Ensure personnel qualifications and competency assessments meet regulatory requirements.
• Maintain systems for tracking credentials and required documentation.
• Support laboratory training and competency programs.

• Provide regulatory and quality guidance to laboratory leadership and technical staff.
• Supervise and develop quality and compliance personnel.
• Work with laboratory operations to address quality concerns and maintain regulatory compliance.
• Oversee staff training and related documentation.
• Present quality metrics, compliance updates and regulatory concerns to executive leadership.

• Bachelor's degree in Healthcare Administration, Life Sciences, Clinical Laboratory Science, Chemistry, Biology, Quality Management, Public Health, Regulatory Affairs or a related field required.
• Master's degree in a related field preferred.

• 7–10 years of related experience in laboratory regulatory compliance, quality management or…