OPTN Compliance Manager

WE ARE SHARING HOPE SC; Charleston, North Charleston (SC, SC); On-site; USD 95,000 - 130,000; Full time

Job summary

Paycom - ATS is seeking an OPTN Compliance Manager in the Charleston area to lead regulatory compliance, patient safety, data integrity, and quality improvement across organ donation programs. The role reports to leadership and supports audits, CAPA, and CMS/OPTN surveys.

The ideal candidate has a 5-year track record in organ procurement and regulatory compliance, with strong analytical and problem-solving abilities and EMR experience (Cerner, Epic, Meditech). On-call duties may apply.

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; risk management experience is a plus.
• Knowledge of OPTN, CMS, and HRSA requirements.
• Strong analytical, auditing, and problem-solving skills.
• Computer skills with Microsoft Office; EMR systems experience preferred; iTransplant experience required.

Responsibilities

• Monitor and ensure compliance with OPTN policies, bylaws, and reporting requirements.
• Coordinate responses to OPTN reviews, audits, and regulatory inquiries.
• Lead patient safety reporting and event management processes.
• Investigate patient safety events, near misses, and CAPA.
• Oversee data validation, quality assurance, and OPTN data submissions.
• Supervise Death Record Review Coordinators and CMS compliance.
• Provide operational oversight of the organization’s research program.
• Deliver regulatory education and lead quality initiatives.

Skills

Analytical skills

Auditing

Problem-solving

Leadership

Education

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

Tools

iTransplant

Cerner

Epic

Meditech

Microsoft Office

Job description

Job Details: Job Location: Charleston - North Charleston, SC 29405, Position Type: Full Time, Job Shift: Day Shift, 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.

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