OPTN Compliance Manager
WE ARE SHARING HOPE SC · Charleston - North Charleston, SC 29405
The OPTN Compliance Manager serves as one of the organization's subject matter experts and supports operational leadership for regulatory compliance, adverse events and patient safety reporting, data integrity, quality improvement, and organizational performance monitoring. This position is responsible for ensuring compliance with OPTN policies and bylaws, HRSA requirements, CMS Conditions for Coverage, and applicable regulations governing organ donation and transplantation. The OPTN Compliance Manager serves as the backup Patient Safety Officer.
Essential Duties & Responsibilities
Regulatory Compliance & OPTN Oversight
• Monitor and ensure compliance with OPTN policies, bylaws, and reporting requirements.
• Coordinate responses to OPTN reviews, audits, and regulatory inquiries.
• Conduct compliance assessments and support regulatory readiness activities.
Patient Safety & Quality Improvement
• Lead patient safety reporting and event management processes.
• Investigate patient safety events, adverse events, near misses, and process deviations.
• Facilitate root cause analyses and corrective/preventive action plans (CAPA).
• Analyze quality data and identify opportunities for performance improvement.
Data Integrity & Regulatory Reporting
• Oversee data validation and quality assurance activities.
• Management and Validation of the OPTN Ventilated Patient Forms (VPFs)
• Audit donor records and OPTN data submissions for accuracy and completeness.
• Investigate data discrepancies and implement corrective actions.
Death Record Review Program Leadership
• Supervise the Death Record Review Coordinators.
• Oversee the Death Record Review Program to ensure CMS compliance and identification of missed donation opportunities.
• Present findings and recommendations to leadership and quality committees.
Research Program Oversight
• Provide operational and regulatory oversight of the organization's research program.
• Ensure compliance with research protocols, and regulatory standards.
• Monitor research data quality and support research-related audits and reporting.
• Collaborate with clinical and operational leaders to advance donation and transplantation research initiatives.
Audit, Survey Readiness & Education
• Coordinate internal compliance audits and support CMS and OPTN surveys.
• Deliver education regarding regulatory requirements, patient safety, and compliance responsibilities.
• Lead assigned organizational committees and quality initiatives.