Senior Director, Lab Quality & Regulatory Excellence

nuCare Medical Solutions, Inc; Frederick (MD); Hybrid; USD 150,000 - 185,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Paid time off

Professional development support

Job summary

nuCARE Medical Solutions, Inc. seeks a Director of Laboratory Quality and Regulatory Compliance to lead a national practice. Hybrid role in Frederick, MD with 25%–40% travel to client sites. Reports to CEO and will design quality systems, lead inspections, and shape service delivery.

You will oversee CLIA, CAP, COLA, and state licensure activities, supervise placed Laboratory Directors and Technical Supervisors, and drive growth through new client engagements and strategic partnerships.

Qualifications

• Bachelor's degree in Clinical Laboratory Science, Medical Technology, Biochemistry, or related life science field.
• 10+ years of progressive clinical laboratory quality assurance or operations experience.
• 3–5 years in a Director-level quality leadership role.
• Deep knowledge of CLIA, CAP, COLA, and state licensure.
• Ability to develop and close new client relationships.
• Willingness to travel 25–40% nationally.

Responsibilities

• Serve as senior SME on CLIA, CAP, COLA, and state licensure.
• Lead mock inspections, gap analyses, and regulatory readiness assessments.
• Establish Quality Management Systems, SOPs, document control, and proficiency testing programs.
• Lead root-cause analysis, corrective and preventive action planning, and remediation after inspections.
• Define and scale the practice — service lines, delivery methodology, and quality standards.
• Provide oversight across client accounts and supervise placements of Laboratory Directors and Technical Supervisors.
• Ensure placements meet CLIA personnel requirements for the testing complexity.
• Develop and close new client engagements and placements; partner with Sales on target outreach.
• Build and lead a consulting team as the practice grows.

Skills

Quality assurance

Regulatory compliance

Leadership

Business development

Travel readiness

Education

Bachelor's degree in Clinical Laboratory Science

Master's degree in related field

Job description

nuCARE Medical Solutions, Inc. seeks a Director of Laboratory Quality and Regulatory Compliance to lead a national practice. Hybrid role in Frederick, MD with 25%–40% travel to client sites. Reports to CEO and will design quality systems, lead inspections, and shape service delivery.

You will oversee CLIA, CAP, COLA, and state licensure activities, supervise placed Laboratory Directors and Technical Supervisors, and drive growth through new client engagements and strategic partnerships.