OPTN Compliance Manager

We Are Sharing Hope SC; North Charleston (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

We Are Sharing Hope SC is seeking a Regulatory Compliance & Quality Improvement leader to oversee OPTN oversight, patient safety programs, data integrity, and research governance within a transplant-focused healthcare organization.

The role requires at least five years in organ procurement and compliance, with deep knowledge of OPTN, CMS, and HRSA standards, and strong analytical skills. On-site position with on-call requirements including weekends and holidays.

Qualifications

• Bachelor's degree in Healthcare Administration, Nursing, Public Health, Quality Management, or related field.
• Five (5) years’ experience in Organ procurement and Quality & Compliance. Consideration will be given to individuals who have experience in transplantation, risk management, equivalent patient safety and risk management.
• Knowledge of OPTN, CMS, and HRSA requirements.
• Strong analytical, auditing, and problem-solving skills.

Responsibilities

• 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.
• Lead patient safety reporting and event management processes.
• Investigate patient safety events, adverse events, near misses, and process deviations.
• Facilitate root cause analyses and CAPA.
• Analyze quality data and identify opportunities for performance improvement.
• 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.
• 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.
• 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.
• 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.

Skills

Five+ years experience

Analytical skills

Auditing

Problem-solving

Regulatory knowledge

Education

Bachelor's degree in Healthcare Admin / Nursing / Public Health / Quality Management

Tools

Microsoft Office

Cerner

Epic

Meditech

iTransplant

Job description

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.

Qualifications

Qualifications, Education & Experience

Education

• Bachelor's degree in Healthcare Administration, Nursing, Public Health, Quality Management, or related field.

Experience

• Five (5) years’ experience in Organ procurement and Quality & Compliance. Consideration will be given to individuals who have experience in transplantation, risk management, equivalent patient safety and risk management.
• Knowledge of OPTN, CMS, and HRSA requirements.
• Strong analytical, auditing, and problem-solving skills

Computer Skills

Microsoft Office products required. Electronic Medical Records (e.g., Cerner, Epic, Meditech) preferred. Experience with iTransplant required.

Other Requirements

Ability to fulfill on-call obligations, including weekends and holidays