CLIA Laboratory Director Full-time

Lighthouse Lab Services is seeking an experienced and dynamic Laboratory Director to lead the Clinical Services (CLN) initiatives at a wellestablished reference laboratory located in Indianapolis IN. The successful candidate will demonstrate the core values of the laboratoryIntegrity Dedication Excellence Accountability Humility and Teamworkwhile guiding the strategic planning and of our diagnostic services. The Laboratory Director will provide effective leadership and change management to ensure that our services meet regulatory requirements quality standards and operational efficiency. This role will also involve the implementation of new tests and services as well as identifying opportunities for process improvements including automation.

Essential Duties and Responsibilities

Organizational Leadership

• Demonstrate the laboratorys core values of Integrity Dedication Excellence Accountability Humility and Teamwork.

• Provide leadership for crossfunctional teams and manage organizationwide change initiatives.

• Promote a culture of continuous improvement and operational excellence.

Regulatory Compliance

• Ensure the CLN meets regulatory and accreditation requirements including CLIA CAP NYS CLEP and FDA standards.

• Oversee preparations for regulatory reviews and audits.

• Review internal audit findings and implement corrective actions as required.

• Ensure laboratory personnel follow appropriate test methods and maintain verification studies for accuracy and performance metrics.

• Maintain and update required regulatory records in accordance with laboratory policies and guidelines.

• Perform oncall duties as needed.

Quality System Management

• Oversee the continuous improvement of the CLN quality system to prevent and identify risks of inaccurate or false test results.

• Monitor and maintain Quality Control (QC) and Quality Assurance (QA) programs.

• Ensure corrective and preventive actions are implemented and documented in response to deviations from established metrics.

• Monitor critical test limits and ensure timely notification of practitioners for corrective actions when necessary.

Collaboration & Outreach

• Collaborate with laboratory directors physicians vendors and other stakeholders to support clinical laboratory operations and investigate potential new tests or services.

• Present research findings at conferences through publications and other professional outlets.

• Develop educational materials for both current and prospective customers.

Growth & Efficiency

• Identify opportunities for new test development technology transfers or acquisitions.

• Lead crossfunctional teams to assess design and implement new lab tests and services.

• Enhance laboratory efficiency focusing on automation and process improvements.

• Provide technical support to laboratorians physicians veterinarians manufacturers and consumers.

Qualifications

Education and Experience

• MD/DO with ABP (CP) ABP (MMB) or AOBP (LM) certifications or equivalent qualifications.

• PhD with HHS Certification that meets CLIA requirements.

• Preferred: NY CLEP Diagnostic Immunology & Mycology CQs.

• Minimum of 5 years of experience as a Laboratory Director.

• Proven experience in Microbiology.

• Demonstrated leadership abilities in a laboratory setting.

Other Requirements

• The Laboratory Director must be qualified to manage laboratory personnel and highcomplexity tests in accordance with 42 CFR 493.1357 and Part 581.2 of 10NYCRR.

• Strong communication skills both verbal and written.

• Ability to manage multiple tasks and prioritize effectively in a fastpaced environment.

• Commitment to the ongoing development and improvement of laboratory services.

Benefits

As a valued member of our team you will enjoy the following benefits:

• 7 Paid Holidays each year.

• Paid Time Off (PTO) for vacation and personal days.

• Tuition Reimbursement to support your ongoing education and career development.

• 2 Weeks of Parental Leave for new parents to bond with their child.

About Us:

At Lighthouse Lab Services we offer solutions to help start grow and run clinical laboratories. Our recruiting team has over 20 years of proven success placing job seekers in positions ranging from entrylevel 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. In addition Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.

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