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nuCare Medical Solutions

Director of Laboratory Quality and Regulatory Compliance

Job Description

About nuCARE Medical Solutions nuCARE Medical Solutions, Inc. is a national laboratory consulting and management firm that helps healthcare providers and diagnostic laboratories build, launch, and operate compliant, high-performing in-house and reference laboratories. Our services span laboratory buildout, laboratory management, technical laboratory oversight and guidance, validation services across molecular infectious disease, pharmacogenetics, toxicology, NGS, and germline cancer diagnostics, and procurement. Compliance is our number one priority, and it is the thread running through everything we deliver. The Opportunity We are looking for a Director of Laboratory Quality and Regulatory Compliance to lead our quality and regulatory practice. This is a senior, high-visibility role reporting directly to the Chief Executive Officer, with real influence over strategy, service design, staffing, and growth. You will serve as nuCARE's senior regulatory authority across CLIA, CAP, COLA, and state laboratory licensure — designing and delivering quality management systems, mock inspections, gap analyses, and remediation programs for client laboratories nationwide. You will also carry quality and compliance oversight across our existing client base, and provide technical oversight of the laboratory personnel we place at client sites, including Laboratory Directors and Technical Supervisors. This is a builder's role. You will shape service offerings, establish the delivery methodology, and grow a team of regulatory and compliance consultants beneath you. It is also a commercially accountable one: you will develop and close new client relationships, working alongside our VP of Sales and drawing on your own network and industry presence. If you have spent years making laboratories survey-ready and have wanted ownership of a practice rather than a function, this is that role. nuCARE supports this position with dedicated lead generation resources and administrative support for client and personnel onboarding, so your time goes to the work that requires your expertise. What You'll Do Quality & Regulatory Leadership

▪ Serve as nuCARE's senior subject matter expert on CLIA regulations, CAP checklists, COLA criteria, and state laboratory licensure frameworks.

▪ Conduct and oversee mock inspections, gap analyses, and regulatory readiness assessments for client laboratories preparing for survey.

▪ Establish customized Quality Management Systems, SOPs, document control processes, and proficiency testing programs for clients.

▪ Lead root-cause analysis, corrective and preventive action planning, and remediation support following inspection findings.

▪ Define and scale the practice — service lines, delivery methodology, and quality standards. Oversight & Technical Support

▪ Provide laboratory quality and regulatory compliance oversight across nuCARE's existing client accounts, maintaining survey readiness between engagements.

▪ Oversee the technical support delivered at client laboratories, including the qualification, performance, and deliverables of the Laboratory Directors and Technical Supervisors nuCARE places.

▪ Ensure every placement satisfies CLIA personnel requirements for the testing complexity and specialties of the receiving laboratory.

▪ Build and maintain nuCARE's network of qualified laboratory personnel — sourcing, credentialing, onboarding, and performance management.

▪ Provide direct laboratory technical support on validation, buildout, and laboratory management projects as needed. Growth & Client Development

▪ Develop and close new client engagements for the quality and regulatory practice, carrying an annual new-business target.

▪ Source and place Laboratory Directors and Technical Supervisors at client laboratories, carrying an annual placement target.

▪ Partner with nuCARE's VP of Sales on targeting, messaging, and lead conversion.

▪ Cultivate referral relationships with laboratory owners, hospital systems, and existing nuCARE clients.

▪ Represent nuCARE at conferences, trade association events, and client meetings.

▪ Build and lead a team of regulatory and compliance consultants as the practice grows. What You Bring

Education:

Bachelor's degree in Clinical Laboratory Science, Medical Technology, Biochemistry, or a related life science field. Master's degree (MHA, MPH, MS) strongly preferred.

Certification:

ASCP board certification (MLS, MT, or DLM) required.

Experience:

10+ years of progressive clinical laboratory quality assurance or operations experience, including 3-5 years in a Director-level quality leadership role.

▪ Regulatory depth: Deep operational command of CLIA regulations, CAP checklists, COLA criteria, and state licensure law.

▪ Personnel qualification: Working knowledge of CLIA personnel requirements for laboratory director, technical supervisor, clinical consultant, general supervisor, and testing personnel roles across moderate- and high-complexity testing.

▪ Client development: A demonstrated record of developing, negotiating, and closing new client relationships in an advisory or consulting setting.

▪ Entrepreneurial range: Comfort building structure where little exists, and moving between strategy and hands-on delivery.

Travel:

Willingness to travel 25%-40% nationally to client laboratory sites and client meetings. Nice to Have

▪ Prior experience as a state or federal clinical laboratory surveyor or inspector.

▪ Quality background in molecular diagnostics, toxicology, or pharmacogenetics environments.

▪ Experience building or scaling a consulting practice or service line.

▪ An established network among laboratory owners, hospital systems, or diagnostics companies. Compensation & Benefits

Base Salary:

$150,000-$185,000 annually, commensurate with experience.

Incentive Compensation:

Performance-based commission on new client engagements and placements, paid as revenue is billed and collected. Structure and targets are reviewed in detail during the interview process.

Benefits:

Health, dental, and vision insurance; paid time off; professional development and certification support. Pay Transparency This posting complies with the Maryland Wage Range Transparency Act, requiring upfront disclosure of pay scales and benefits for work performed in Maryland. How to Apply Submit your resume and a brief note on the laboratories you have taken through survey. We review every application and respond to candidates who meet the qualifications above. nuCARE Medical Solutions, Inc. is an equal opportunity employer. All qualified applicants will receive consideration without regard to any characteristic protected by applicable federal, state, or local law.

Pay:

$150,000.00 - $185,000.00 per year

Benefits:

Dental insurance Health insurance Vision insurance

Work Location:

Hybrid remote in Frederick, MD 21703

Benefits

  • Paid Time Off (PTO)
  • Professional Development
  • Health Insurance
  • Dental Insurance

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What they do

A Compliance Manager tracks employer compliance with laws and regulations, particularly for organizations in business and health care. Creates company policies, reviews departmental functions and protocol, follows developments in law and regulations affecting the industry

$161,994 / year median in Maryland

+3% projected growth

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