Director of Quality Regulatory Affairs

Description

The Director of Quality & Regulatory Affairs (DQRA) is responsible for assisting the Chief Quality Officer (CQO) with the execution of the SFDN Quality Management System including continual quality improvement throughout the organization. Directs the development, implementation and monitoring of quality systems and regulatory compliance related to internal standards, industry standards, state, local and federal regulations, departmental and organizational goals and processes.

Assist with the overall direction for consistency and training for those managed. The Director serves as an advocate and resource for quality programs and provides interpretations of regulations and standards for consideration in the formulation of business strategies related to organ, tissue, and ocular recovery as well as administrative operations.

• Directs, manages, and provides oversight for all activities related to the Quality Management System (QMS) and performance improvement.
  • Develops and maintains a quality plan to ensure the best service possible. Oversees the implementation of the SFDN’s QMS. Activities include licensing, performance improvement, customer complaint, planned deviation, corrective action/preventive action, auditing, document control, chart QA, validation, and death record review systems.
  • Promotes quality assurance with the expectation of accurate donor medical records and data elements, and validation of all performance data.
  • Implements, monitors and reviews systems and programs that provide consistent adherence to policies related to organ, tissue and ocular recovery, laboratory, and administrative operations.
  • Responsible for the administration of the electronic quality management system platform.
• Ensures organizational compliance with regulatory standards including AHCA, AOPO, OPTN/HRSA, CDC, and CMS. Ensures all regulatory and governmental licenses are kept current.
  • Monitors and analyzes information release and activity pertaining to federal, state, and industry standards as it relates to regulatory compliance and organizational operations.
  • Ensures policies and procedures reflect regulations and standards and collaborates to revise them as needed.
• Will be listed as the Patient Safety Contact with OPTN/HRSA as well as serve as the Patient Safety Officer.
  • Responsible for monitoring and investigating patient safety events in real time, serving as the first point of contact for families, hospital partners, and HRSA; documenting and reporting incidents and adverse events to OPTN.
• Develops, oversees and maintains a quality plan that aligns to the SFDN Quality Manual and Quality Excellence Program (QEP) in order to advance the SFDN mission and core purpose.
• Deploys and maintains an effective QMS to foster a culture of continuous improvement through data analysis in collaboration with all SFDN departments.
  • Promotes use of the organization’s quality improvement process by evaluating, improving workflow, and maximizing process efficiencies.
• Assists in the development and analysis of all statistical performance measurements of organ, tissue, and administrative operations, and quality and regulatory compliance throughout the organization. Conducts ongoing monitoring and data analysis, trending and reporting of the quality management systems including but not limited to occurrences (non-conformances), planned deviations, customer complaints, sentinel events, and adverse reactions and outcomes. Identifies opportunities for improvements.
  • Reports meaningful data related to activity levels, quality measures, and regulatory compliance to SFDN leadership, staff, advisory board members, and various stakeholders.
• Collaborates with other organ, tissue and recovery agencies to keep current on industry best practices and works to deploy the same in the organization.
• Represents SFDN at various meetings and conferences including the Association of Organ Procurement Organization (AOPO). Promotes SFDN and the brand through actively participating and presenting at these conferences.
• Manages the selection, training, development, and performance of assigned staff to retain a motivated, professional…