Position Overview

A leading diagnostics organization is seeking a Director, Laboratory Quality & Compliance to lead quality systems and regulatory compliance across its laboratory operations. This individual will be responsible for ensuring adherence to all applicable regulatory and accreditation standards while driving continuous quality improvement, patient safety, and operational excellence.

This is a highly visible leadership role working cross-functionally with laboratory leadership and executive stakeholders.

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Key Responsibilities

Regulatory & Accreditation Compliance

• Ensure full compliance with CLIA, CAP, FDA, and applicable state regulations
• Lead all inspection readiness activities, including audits and accreditation surveys
• Serve as the primary point of contact for regulatory agencies and accrediting bodies
• Interpret new and evolving regulations and implement changes across laboratory operations

Quality Management System (QMS)

• Oversee and continuously improve the laboratory Quality Management System
• Drive quality initiatives including audits, CAPA, and risk management processes
• Monitor quality metrics, identify trends, and present insights to leadership

Audits, Investigations & CAPA

• Lead internal audits to ensure adherence to policies, procedures, and regulatory standards
• Investigate nonconformances, complaints, and adverse events
• Conduct root cause analyses and ensure effective corrective and preventive actions

Policy & Document Control

• Oversee development and maintenance of SOPs, policies, and controlled documents
• Ensure document control processes meet regulatory and accreditation standards

Training & Competency

• Partner with leadership to ensure staff training and competency programs meet requirements
• Provide ongoing compliance education and guidance across the organization

Leadership & Collaboration

• Collaborate with medical directors, laboratory leadership, and technical teams
• Promote a culture of quality, compliance, and continuous improvement

Reporting & Communication

• Prepare and present quality and compliance reports to senior leadership
• Maintain accurate documentation of compliance activities and outcomes

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Qualifications

• Master’s degree in Medical Laboratory Science, Biology, Chemistry, Healthcare Administration, or related field
• 10+ years of experience in clinical or pathology laboratory settings
• Strong knowledge of CLIA, CAP, FDA, and applicable regulatory frameworks
• Experience leading quality management systems, audits, and CAPA processes
• Background in molecular diagnostics (e.g., NGS, PCR) and/or pathology workflows preferred
• Proven leadership experience within laboratory or quality environments
• Strong analytical, problem-solving, and communication skills