VP/Director of Quality & Compliance

At Kashi Clinical Laboratories, the Head of Quality and Compliance is responsible for leading the development, implementation, and oversight of the quality management and regulatory compliance programs within our clinical research laboratory. This leadership role ensures compliance with applicable federal, state, and international regulations—including CLIA, CAP, FDA (GCP, GLP), HIPAA, and Medicare billing regulations—while promoting a culture of wellness, integrity, and operational excellence. This leader also ensures appropriate billing practices and documentation to support compliance with CMS (Centers for Medicare & Medicaid Services) rules and reimbursement requirements. Key Responsibilities: Quality Management & Regulatory Compliance: Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with regulatory and accreditation standards. Ensure compliance with applicable laboratory regulations including CLIA, CAP, GCP, GLP, FDA, HIPAA, and ISO 15189. Lead and coordinate internal and external audits, inspections, and remediation activities (CAPAs). Oversee laboratory document control, validations, deviations, non-conformances, and change control. Serve as the primary liaison with regulatory agencies and accreditation bodies during inspections and audits. Prepare and manage regulatory submissions, responses, and reports as required. Medicare Billing Compliance: Oversee and ensure compliance with CMS billing regulations, including Medicare Local Coverage Determinations (LCDs), National Coverage Determinations (NCDs), and other payer requirements. Collaborate with the billing, coding, and revenue cycle teams to ensure accurate documentation, medical necessity, and timely claim submissions. Establish controls and audits to detect and correct billing errors or fraud risks. Develop and maintain policies and procedures related to laboratory test coding (e.g., CPT, HCPCS), claim submission, and billing audits. Ensure laboratory staff are trained on billing compliance requirements relevant to clinical testing services. Training and Documentation: Ensure all laboratory staff are trained on SOPs, quality standards, and compliance expectations. Maintain complete, accurate, and auditable documentation for all regulatory and billing compliance activities. Risk Management & Continuous Improvement: Develop and track quality and compliance metrics and KPIs. Proactively identify compliance risks and drive mitigation strategies. Lead continuous improvement initiatives across lab operations and business processes. Financial Practice Monitoring Review and monitor all marketing, sales, and referral arrangements for compliance with EKRA restrictions. Partner with Human Resources and Legal to develop compliant commission and incentive compensation plans for employees and contractors. Review laboratory policies, procedures, and compensation structures to ensure compliance with federal and state anti-kickback laws. Conduct regular audits of financial and contractual relationships to identify and mitigate EKRA-related risks. Team Leadership & Cross-functional Collaboration: Lead and mentor a team of quality assurance, regulatory affairs, and billing compliance professionals. Collaborate with Clinical Affairs, Laboratory Operations, R&D, Legal, and Finance teams to ensure compliance alignment across the organization. Qualifications: Education:

Bachelor's degree in Life Sciences, Clinical Laboratory Science, Health Administration, or a related field (required). Advanced degree (MS, MPH, MBA, or PhD) preferred.

Experience:

8–10 years of experience in quality, regulatory, or compliance roles within a clinical laboratory or healthcare setting. At least 3–5 years in a leadership capacity. Experience with Medicare billing and CMS regulations in a lab environment is required. Prior experience with third-party payers, revenue cycle management, and audit processes is highly desirable.

Certifications (Preferred):

ASQ Certified Quality Auditor (CQA), RAC, CHC (Certified in Healthcare Compliance), or equivalent. Certification/licensure in Clinical Laboratory Science or Coding/Billing Compliance (e.g., CCS, CPC) and/or Certified Compliance & Ethics Professional (CCEP) is a plus.

Key Competencies: Deep understanding of CLIA, CAP, FDA (GCP/GLP), HIPAA, and CMS Medicare billing requirements. Strong knowledge of medical coding (CPT, HCPCS), coverage guidelines, and audit processes. Excellent leadership, communication, and problem-solving skills. Ability to build cross-functional relationships and lead teams through complex regulatory environments. Meticulous attention to detail and a proactive approach to risk identification and mitigation.

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