Director of Lab Regulatory & Quality

Job Summary:

The Director of Lab Regulatory and Quality leads and integrates regulatory compliance, credentialing oversight, and quality management across the organization. This role ensures adherence to all applicable federal, state, accrediting, and professional standards while fostering a culture of continuous improvement, patient safety, and operational excellence. The Director partners closely with Revenue Cycle Management on state licensure enrollment and documentation, collaborates with Clinical Affairs on technical assessments and studies required by Medicare Administrative Contractors, and oversees state positivity and CDC reporting. In addition, this role provides leadership over quality assurance, training development, document control, and regulatory reporting, ensuring ongoing readiness for audits and inspections under CAP, CLIA, and OSHA requirements. Serving as a key advisor to executive leadership, laboratory leadership, and clinical teams, the Director translates complex regulatory requirements into effective policies, systems, and operational practices.

Essential Responsibilities/Duties:

Regulatory Leadership

• Ensure organizational compliance with applicable regulatory and accrediting bodies (e.g., CLIA, CAP, CMS, state agencies NYS, CA).
• Lead regulatory readiness activities, including inspections, surveys, audits, and follow-up actions.
• Develops and Submits Technical Assessment and associated studies required by MACs.
• State positivity and CDC reporting as required by each state.
• Interpret regulatory requirements and translate them into policies, procedures, and operational controls. Monitor regulatory changes and proactively assess organizational impact.
• Serve as primary liaison with regulatory agencies and accrediting organizations.

Credentialing Oversight

• Oversee credentialing, licensure, certification, and recredentialing processes for applicable personnel.
• Ensure systems are in place to track expirations, renewals, and compliance with scope of practice requirements.
• Support competency assessment programs aligned with regulatory and accreditation standards.

Quality Management & Performance Improvement

• Lead the organization’s Quality Management System (QMS).
• Oversee incident management, nonconformance reporting, CAPA, Process line audits and root cause analysis activities.
• Establish quality metrics, dashboards, and reporting structures.
• Lead or support process improvement initiatives to reduce risk, improve outcomes, and prevent recurrence of failures.

Audit, Investigation & CAPA

• Direct internal audits and risk assessments.
• Lead investigations of significant events, near misses, and mass failures.
• Ensure timely, effective corrective and preventive actions.
• Track NCE/CAPA effectiveness and sustainability.

Leadership, Training & Culture

• Provide training and guidance to leaders and staff on regulatory, credentialing, and quality expectations.
• Partner with operational leaders to embed quality and compliance into daily workflows.
• Mentor and develop quality and compliance staff; oversee training content development, delivery, effectiveness assessment, and documentation.

Reporting & Governance

• Prepare and present reports to executive leadership.
• Escalate risks appropriately and recommend mitigation strategies.
• Support strategic planning with data-driven quality and compliance insights.

Qualifications:

Education –

• Bachelor’s degree in a relevant field; Healthcare Administration, Business, Life Sciences, Biological, Chemical, or Clinical Sciences field, Quality Management, Public Health, or Regulatory Affairs.
• Master’s degree (MBA, MHA, MPH, MS in Regulatory Affairs or Quality)

Competencies/Skills –

• Excellent verbal and written communication skills
• Ability to communicate effectively with various level stakeholders, including Executive Management
• Ability to multi-task and manage multiple concurrent projects at a departmental level

Experience –

• Leadership experience in regulatory affairs, healthcare credentialing, quality assurance, compliance, or related functions.
• Proven record of managing cross-functional teams and leading complex organizational processes.
• Experience with audits, surveys, and regulatory inspections at state/federal levels