Laboratory Director

Summary of Responsibilities

Demonstrates MVD values and leadership capabilities while guiding strategic planning and execution of Clinical Services (CLN) initiatives. Provides effective cross-functional leadership and change management to ensure diagnostic services consistently meet practitioners’ needs through regulatory compliance, quality systems, training, and efficient customer service and clinical consultation. Implements new tests and services, and identifies opportunities for efficiency improvements, including automation. Recognizes and escalates deficiencies to the Medical Director as needed. Enhances MVD's reputation through publications, presentations, and other communications.

Essential Duties and Responsibilities

• Organizational Leadership
• Demonstrate MVD Values: Integrity, Dedication, Excellence, Accountability, Humility, and Teamwork.
• Effectively lead cross-functional teams and drive change management organization-wide.

• Regulatory Compliance
• Ensure CLN is in compliance with regulatory/accrediting agencies including CLIA, CAP, NYS CLEP, and FDA.
• Oversee regulatory review preparations.
• Review internal audit results and implement corrective actions as needed.
• Ensure the Clinical Laboratory proficiency testing (PT) program meets regulatory requirements.
• Review PT results and implement effective corrective and preventative actions when necessary.
• Ensure laboratory personnel are trained and follow test methods.
• Ensure verification studies demonstrate test accuracy, precision, and other vital performance metrics.
• Ensure test reports include required interpretative and regulatory information.
• Maintain records per MVD policy and regulatory guidelines.
• Be available for on-call duties.

• Quality System
• Oversee the continuous improvement of the CLN quality system.
• Maintain QC and QA programs to prevent and identify risks of false or inaccurate test results.
• Ensure corrective and preventive actions are documented for deviations to established metrics.
• Verify patient test results are reported only when the quality system functions properly.
• Establish and monitor critical test limits, ensuring immediate practitioner notification and corrective actions when appropriate.

• Collaboration & Outreach
• Collaborate with laboratory directors, physicians, vendors, and others to support Clinical Laboratory activities and investigate potential new tests/services.
• Disseminate research findings through publications, conferences, and other channels.
• Develop educational materials for current and potential customers.

• Growth & Efficiency
• Identify opportunities for new test development or technology transfer/acquisition.
• Lead cross-functional teams in assessing, designing, and implementing new lab tests and services.
• Enhance CLN efficiency, including laboratory automation implementation.
• Provide technical support to laboratorians, physicians, veterinarians, manufacturers, and consumers.

Qualifications

The Laboratory Director must be qualified to manage and direct laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of 42 CFR 493.1357 and Part 58-1.2 of 10NYCRR.

Education and Experience

• MD/DO* ABP (CP), ABP (MMB), AOBP (LM) Certifications or equivalent qualifications
• PhD* HHS Certification that meets CLIA requirements

*NY CLEP Diagnostic Immunology & Mycology CQs (preferred but not required)

AND

• ≥5-years experience as laboratory director
• Microbiology experience
• Demonstrated leadership ability