Director of Quality Assurance | Clinical Diagnostic Laboratories

Job DescriptionDirector of Quality Assurance – Clinical Diagnostic Laboratories

Company: nuCARE Medical Solutions, Inc.

Location: Frederick, Maryland (Hybrid — on-site client/lab visits required; remote flexibility for administrative work)

Department: Quality Assurance & Regulatory Compliance (New Division)

Reports To: Chief Executive Officer

FLSA Status: Exempt, Full-Time

Position Type: New / Startup Division Leadership Role

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 services, laboratory management services, technical laboratory oversight and guidance, validation services (molecular infectious disease, pharmacogenetics, toxicology, NGS, germline cancer diagnostics), and procurement services. nuCARE is expanding into a dedicated Quality Assurance and Regulatory Compliance consulting division, and this role will be the founding leader of that practice.

Position Summary

nuCARE is launching a new Quality Assurance & Regulatory Compliance division to serve our clinical laboratory clients with CLIA, CAP, COLA, and state-level licensure readiness, quality management system (QMS) development, mock surveys, and inspection/audit support. The Director of Quality Assurance will build and lead this division from the ground up — designing service offerings, establishing quality systems and SOPs, hiring and training regulatory consulting staff, and directly serving as the senior QA/compliance expert for client engagements. This is a “player-coach” role: the Director is directly responsible for generating new business. Because this division has no existing client base, the Director must personally identify, pursue, and close new client engagements — building a sales pipeline in addition to delivering the QA/compliance work itself. The Director will work closely with nuCARE’s VP of Sales to develop and convert internally generated leads, while also being expected to self-generate new business through their own outreach and network. This is a high-visibility, entrepreneurial role reporting directly to the CEO, with significant influence over the division’s strategy, staffing, and growth trajectory.

Key ResponsibilitiesBusiness Development (Core Responsibility)

·        Personally originate and close new client engagements for the QA & Regulatory Compliance division — this role carries a year-one quota of 10 new client accounts, not just a delivery mandate.

·        Work closely with nuCARE’s VP of Sales to generate and convert leads for the division — coordinating on targeting, messaging, and lead handoff for prospective clients sourced through nuCARE’s broader sales function — while also independently self-generating new business.

·        Build and manage a sales pipeline: identify prospective clinical laboratory clients, initiate outreach, deliver proposals, and negotiate and close contracts.

·        Cultivate referral relationships with laboratory owners, hospital systems, and existing nuCARE clients (buildout, laboratory management, technical oversight, validation, and procurement) to cross-sell QA/compliance services.

·        Represent nuCARE at industry conferences, trade association events, and prospective-client meetings as the face of the QA/Compliance practice, with an explicit business-development (not just brand-awareness) objective.

·        Report on pipeline, new client bookings, and revenue attainment against target directly to the CEO on a monthly basis.

Quality Assurance & Regulatory Delivery

·        Design, launch, and scale nuCARE’s Quality Assurance & Regulatory Compliance consulting division, including service line definition, pricing, and delivery methodology.

·        Serve as lead subject matter expert on CLIA, CAP, COLA, state laboratory licensure, and other applicable federal/state regulatory frameworks for clinical, molecular, and toxicology laboratories.

·        Conduct and oversee mock inspections, gap analyses, and readiness assessments for client laboratories preparing for CMS, CAP, COLA, or state health department surveys.

·        Develop, implement, and maintain Quality Management Systems (QMS), SOPs, document control processes, and proficiency testing programs for client engagements.

·        Lead root cause analysis, corrective and preventive action (CAPA) planning, and remediation support following inspection findings or quality events.

·        Build and manage a team of regulatory/QA consultants as the division grows, including recruiting, training, and performance management.

·        Partner with nuCARE’s laboratory buildout, laboratory management, technical oversight, validation, and procurement teams to embed quality and compliance requirements into new lab launches from day one.

·        Track and report division KPIs (client audit pass rates, engagement pipeline, revenue) directly to the CEO and executive leadership.

·        Stay current on evolving CLIA, CAP, FDA (LDT), and state regulatory requirements and translate changes into client-facing guidance and internal training.

Required Qualifications

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

·        Minimum 10 years of progressive experience in clinical laboratory quality assurance, regulatory compliance, or laboratory operations, including at least 3-5 years in a Director-level or equivalent QA leadership role.

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

·        Deep working knowledge of CLIA, CAP, COLA, and state clinical laboratory licensure requirements; direct experience with CMS/state surveyor processes (as an inspector or as the inspected party) is a significant plus.

·        Demonstrated experience building or managing a Quality Management System (QMS) in a clinical, molecular, or reference laboratory setting.

·        Experience with proficiency testing programs, document control, CAPA processes, and audit/inspection readiness.

·        Prior experience at a startup, newly launched laboratory, or new division/practice build is strongly preferred — comfort operating without established infrastructure.

·        Demonstrated track record of business development or sales in a consulting, advisory, or professional services setting — this role requires the individual to independently generate and close new client business, not solely deliver against an existing book.

·        Excellent written and verbal communication skills; ability to translate complex regulatory requirements for both technical and executive audiences, and to sell nuCARE’s services persuasively to prospective clients.

·        Willingness to travel to client laboratory sites and prospective-client meetings as needed (estimated 25-40%).

Preferred Qualifications

·        Prior experience as a state or federal clinical laboratory surveyor/inspector (e.g., state Department of Public Health CLIA surveyor).

·        Experience in molecular diagnostics, toxicology, or pharmacogenetics testing environments.

·        Prior consulting or client-facing advisory experience, including direct responsibility for a sales quota or new-business target.

·        Experience building a team or practice area from an initial headcount of one.

·        Existing network of relationships with clinical laboratory owners, hospital systems, or diagnostics companies that could translate into an early client pipeline.

Compensation & Benefits

·        Base salary: $150,000–$185,000, commensurate with experience (see attached Executive Brief for full market benchmarking).

·        Year-one new-business quota: 10 new self-generated client accounts (approximately $36,000–$60,000 in first-year contract value per account).

·        New-business commission (core component, not optional; tiered by lead source): 15% of first-year contract value on client engagements sourced from internally generated leads (e.g., leads generated in partnership with nuCARE’s VP of Sales, nuCARE referrals, or marketing-sourced prospects), and 20% of first-year contract value on client engagements the Director personally self-generates. Paid as revenue is billed and collected. At full attainment of the year-one quota, commission alone is projected at $54,000–$120,000 depending on lead-source mix and deal size.

·        Health, dental, and vision insurance; paid time off; professional development and certification support.

Note: This posting complies with the Maryland Wage Range Transparency Act (effective October 1, 2024), which requires disclosure of the wage range, benefits, and other compensation for positions performed, at least in part, in Maryland (Maryland Department of Labor).

Location & Travel

Based at nuCARE’s Frederick, Maryland office, with regular travel to client laboratory sites nationally (estimated 25-40% travel).