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 Leadership
• Serve as the primary quality liaison for regulatory bodies, accreditation organizations, and external auditors.
• Interpret evolving regulatory guidance and translating 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.
• Performs other job-related duties as assigned that are consistent with the purpose of the role.

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.

Compliance:

• This position is classified as OSHA Bloodborne Pathogens Exposure Category III. Employees in this role are not routinely expected to perform tasks that involve contact with blood, bodily fluids, or other potentially infectious materials.
• While exposure risk is minimal, employees are expected to follow organizational safety policies and report any potential exposure incidents immediately.
• This role requires compliance with HIPAA and all confidentiality standards related to patient, donor, employee, and organizational information. Employees must safeguard all confidential information and disclose it only as permitted by law and organizational policy.

Physical Environment / Working Conditions:

Sedentary Work - Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Roles are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Other:

Southwest Transplant Alliance maintains a policy of nondiscrimination with employees and applicants for employment. No aspect of employment will be influenced in any manner by race, color, religion, sex, age, national origin, physical or mental disability, genetics, sexual orientation, gender identity, gender expression, or any other basis prohibited by statute. In addition to federal law requirements, STA complies with applicable state and local laws governing nondiscrimination in employment in every location in which the STA has staff.

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.