Director of Quality Systems

Summary

The Director of Quality is responsible for leading the organization’s quality and performance improvement strategy, ensuring alignment with regulatory standards and organizational priorities. This role oversees key quality functions, including documentation review, regulatory reporting, and data monitoring, to drive accuracy, compliance, and operational effectiveness.

Strategic Thinking

• Provide strategic leadership for the organization’s Quality Assessment and Performance Improvement (QAPI) program, ensuring alignment with organizational goals, regulatory requirements, and long-term performance objectives.
• Lead and oversee organ and tissue chart review processes to ensure completeness, accuracy, regulatory compliance, and adherence to best documentation standards.
• Conduct and supervise CMS-required death record reviews to identify missed referrals, trends, documentation gaps, and systemic improvement opportunities.
• Direct OPTN reporting and data submission activities, ensuring timely, accurate, and compliant reporting aligned with OPTN and UNOS requirements and internal quality standards.
• Establish enterprise-wide quality monitoring systems that proactively identify risk, process variation, and performance trends.
• Develop and track meaningful quality metrics and dashboards related to chart review, death record review, reporting accuracy, and compliance outcomes, communicating findings to executive leadership and the Board as appropriate.
• Drive continuous improvement initiatives by translating data insights into strategic operational improvements.

Risk Management

• Manage the organization’s variance management system, including assignment of severity levels, oversight of investigations, root cause analysis, and development and monitoring of corrective and preventive action (CAPA) plans.
• Maintain data integrity across systems, identifying discrepancies, systemic risks, and opportunities for corrective action.
• Support readiness for regulatory surveys, audits, and accreditation activities through proactive quality monitoring, mock surveys, and documentation oversight.
• Identify emerging regulatory, operational, and compliance risks and proactively implement mitigation strategies.
• Ensure adherence to CMS, OPTN, and applicable federal and state regulatory standards.

Financial Acumen

• Evaluate the financial impact of quality initiatives, regulatory findings, documentation errors, and process inefficiencies; develop cost-effective improvement strategies.
• Align quality improvement priorities with organizational financial goals to reduce risk exposure, prevent financial penalties, and protect reimbursement.
• Develop and manage the Quality department budget, ensuring appropriate allocation of resources, technology investments, and staffing to support compliance and performance goals.
• Leverage data analytics and reporting systems to improve operational efficiency and reduce waste or duplication.
• Audit processes and system enhancements for ROI assessment.

Team Leadership & Culture

• Provide direct leadership and oversight of quality team members, ensuring clarity of expectations, accountability, professional development, and succession planning.
• Foster a culture of transparency, learning, and psychological safety that encourages reporting of variances and near misses.
• Provide quality-focused consultation and education to staff and leadership to strengthen quality culture and promote consistent performance improvement.
• Facilitate cross-department collaboration to support continuous quality improvement initiatives organization-wide.
• Establish feedback loops between Quality and operational teams to ensure shared ownership of performance outcomes.
• Model data-driven decision-making and promote accountability at all levels of the organization.

Regulatory & External Affairs Leadership

• Serve as the primary quality liaison for regulatory bodies, accreditation organizations, and external auditors.
• Interpret evolving regulatory guidance and translate requirements into operational standards.
• Present quality performance, risk trends, and corrective action plans to executive leadership and governance bodies.
• Represent the organization in external quality collaboratives, benchmarking initiatives, and industry forums.

Education, Experience, And Licensing Requirements

• Bachelor’s degree in health care administration, public health, nursing, or business is required. Master’s degree is preferred.
• A combination of alternative education and experience may be considered in lieu of the formal education requirements.
• Minimum of 5 years of experience in the management of Quality Systems to include reporting and analytics is required.
• Experience in healthcare, OPO, transplant center, or related industry regulatory industry is preferred.
• Current Driver’s License is required and maintained with an acceptable driving record as defined by STA policy.

Disclaimer

This job description is intended to describe the general nature and level of work performed. It is not an exhaustive list of responsibilities, duties, or skills required. Job duties may change at any time with or without notice. Nothing in this description constitutes a contract of employment, and employment remains at-will.