The Manager of Quality and Regulatory Affairs is responsible for the planning, development, implementation, and continuous evaluation of the organization's regulatory compliance, risk management, and quality improvement programs. This role ensures alignment with regulatory requirements and organizational goals by leading the Quality Assurance and Process Improvement team. The Manager promotes high-quality organ procurement practices while safeguarding the organization's regulatory standing as outlined by federal, local, and state regulatory bodies. They actively contribute to policy development, support an organizational culture based on collaboration and feedback, and ensure the organization remains accreditation- and audit-ready across all required regulatory bodies. The Manager is also engaged in proactively outlining process improvement opportunities and collaborating with the Director of Governance and Data Strategy and the rest of the organization as required. The Manager is responsible for overseeing daily operations and departmental KPIs, developing long-term strategies, and staying informed of healthcare and regulatory changes that may impact organizational compliance, quality, and risk management.

REGULATORY COMPLIANCE/ACCREDITATION

• · Ensure ongoing compliance with AOPO, OPTN, UNOS, CMS, FDA, SRTR, CDC, and State Health Department requirements.
• · Lead the organization’s readiness for audits, certifications, and inspections.
• · Oversee timely and accurate regulatory reporting.
• · Maintain active participation in industry regulatory and accreditation committees as appropriate.

QUALITY IMPROVEMENT

• Assist leadership in developing and updating the organization’s Quality Plan in accordance with CMS 486.348. 
• Provide all required Quality Assessment and Performance Improvement (QAPI) reports to partner institutions and stakeholders as required by CMS 486.348 and 486.324
• Prepare regulatory reports and data submissions and respond to compliance findings from federal or accrediting bodies. 
• Lead data analysis and trend reporting to monitor and enhance donor activity. 
• Coordinate annual mandatory training related to quality assurance and quality improvement. 
• Collaborate with multiple organizations or partners to ensure alignment and compliance with shared regulatory, accreditation, and quality standards. 
• Ensure compliance through the entirety of the referral, donation and transplant process as is required for the OPO. 
• Ensure policies and procedures are reviewed as required and align with organization and industry standards. 
• Collect, prioritize, and oversee Process Improvement initiative requests with direction of the Director of Governance and Data Strategy. 
• Obtain and maintain expert-level understanding of operational roles and provide staffing support during periods of low staffing or high volume.
• Identify process improvement opportunities, review and outline process improvement plans, oversee progress, set measurable goals, and develop corrective action plans with timelines.

RISK MANAGEMENT

• Collect, monitor, and analyze quality and risk management data in collaboration with the Business Intelligence team and Business Intelligence leadership.
• Identify and mitigate risk exposure by recommending preventative measures and immediate actions.
• Conduct root cause analyses, sentinel event investigations, and implement corrective/preventative action (CAPA) plans.
• Develop, maintain, and revise safety and compliance policies and procedures.
• Serve as liaison with other organ procurement organizations to share risk management strategies and collaborate on initiatives.
• Provide risk management education to the Advisory Board and staff.

Other Duties as Assigned

• Bachelor’s degree in health sciences, Quality or a related field as determined by the department.
• Minimum of five (5) years of Quality Assurance Program experience. 
• Minimum of two (2) years recent experience in a leadership position.
• Minimum of two (2) years of experience in one or more areas related to organ, eye, tissue, plasma, blood donation or health care programs.

Job Related Knowledge, Skills and Abilities (Competencies):

• Compliance for Federal or large organization regulatory experience (JCAHO, FDA, CMS, HRSA, AOPO, UNOS etc.). 
• Experience using, analyzing, and leveraging data.
• Strong experience working across departments (clinical, operations, IT, HR) to implement system-wide quality initiatives.
• Experience using Power Bi, Tableau, or similar.
• Experience developing materials, SOPs, and other required tools designed to encourage a self-sufficient team with resource materials for shared work.
• Experience tracking and overseeing projects to ensure the department and organization stay on track towards meeting strategic goals. 
• Experience creating, enforcing, and managing policies, procedures, and job aids.
• Experience leading investigations into quality issues and managing corrective and preventative actions. 
• Strong written and verbal communication skills.
• Ability to motivate and lead teams to achieve quality outcomes.
• Strong organizational, problem-solving, analysis, and decision-making skills.
• Ability to assess and create solutions for complex quality and compliance issues.
• Skilled in motivating staff and facilitating process improvement initiatives.
• Ability to effectively manage multiple projects with attention to detail and deadlines. 
• Skilled in developing training programs and educational materials for staff. 
• Ability to approach subjects with grace and curiosity with the goal of collaborating and developing a solution to a shared problem.

• Master’s degree in Regulatory Science, Healthcare Administration, Public Health, or a related field as determined by the department.
• Certified Professional in Healthcare Quality (CPHQ)
• Significant experience at the management level overseeing Quality, Compliance, or Risk Management.
• Experience managing standard or point-of-care testing programs.
• Hands-on experience leading internal and external audits, including preparation, response, and corrective action planning, especially for CMS, FDA, AOPO, UNOS, and other healthcare regulatory bodies. 
• Experience developing and managing Process Improvement initiatives.
• Experience leading multiple teams. 
• Experience overseeing a medical record and/or validating regular software releases. 
• Publications or committee work with professional organizations.

• Able to work a minimum of 40 hours per week, predominantly in office.

   

• Required to work for extended periods of time with few breaks.

   

• Must be able to travel within the service area and nationally by ground or air.

   

• Work schedules will vary depending on needs of the department.

   

• Work with human organs/tissue/blood.

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.