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. The Director of Quality is responsible for identifying risks, leading investigations, and implementing corrective actions that strengthen performance and reduce variability across systems and processes.

Through data-driven insights, this position establishes meaningful metrics and dashboards to inform decision-making and support continuous improvement initiatives. The role partners with leaders across the organization to promote accountability, consistency, and a culture focused on quality and safety. Additionally, the Director of Quality ensures preparedness for audits and accreditation activities while serving as the primary liaison for regulatory agencies and external stakeholders.

Financial stewardship is also a key component, aligning quality initiatives with resource optimization and organizational sustainability.

Essential Job Functions and Responsibilities:

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.UNOS requirements and internal quality standards.
• Establish enterprise-wide quality monitoring systems that proactively identify risk, process variation, and performance trends.
• Lead structured policy and procedure review cycles to ensure alignment with regulatory standards, best practices, and organizational priorities.
• 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.
• Monitor data integrity across systems, identifying discrepancies, systemic risks, and opportunities for corrective action.
• Oversee document control processes to ensure current, standardized, and compliant policies, procedures, and forms across the organization.
• 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.
• Assess return on investment (ROI) for quality initiatives, audit processes, and system enhancements.

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…