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.

About the Client

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.

Position Overview

The Director of Laboratory Regulatory & Quality will lead the organization's Quality ManagementSystem (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.

Key Responsibilities

Regulatory Compliance & Accreditation

• 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.

Quality Management & Process Improvement

• 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.

Credentialing & Personnel Compliance

• 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.

Leadership & Regulatory Guidance

• 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.

Qualifications

Education

• 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.

Experience

• 7–10 years of related experience in laboratory regulatory compliance, quality management or healthcare credentialing.
• Leadership experience overseeing laboratory quality and regulatory programs.
• Strong knowledge of CAP, CLIA, CMS and applicable state laboratory regulations.
• Experience with regulatory inspections, audits, surveys and corrective action programs.
• Experience managing teams and working across departments.
• High-complexity clinical laboratory experience preferred.

Additional Qualifications

• Strong written and verbal communication skills.
• Ability to manage multiple projects and work independently.
• ASCP certification or applicable quality credentials, such as ASQ or Six Sigma, preferred.
• Ability to travel approximately 20% of the time.

Work Environment

This position involves administrative work and oversight of clinical laboratory operations. Responsibilities may require extended computer use, occasional lifting of up to 10 pounds and working in laboratory environments where biological or chemical hazards may be present.

Pay and Schedule:

• This role is a remote position with approximately 10 hours per week

• Pay rate is generous and based on background and experience

About us:

At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 23 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Lighthouse Lab Services is committed to working and providing reasonable accommodation to individuals of all abilities, including persons with disabilities.

If at any time during the application process, you need accommodation, please contact [email protected] for assistance.

Lighthouse Lab Services | 844-974-1929 | lighthouselabservices.com

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