The Division of Pediatric Critical Care Medicine at the University of Utah School of Medicine has an immediate opening for a Director of Quality.This position offers an exciting opportunity to work in the Clinical Research Enterprise Data Coordinating Center (DCC) leading, directing and developing the Quality Management Program. Responsibilities include risk assessment training and evaluation, SOP development and maintenance.Also includes directing, developing and coordinating staff education that will continue to build and reinforce the culture of quality in the DCC.Will oversee the implementation of the risk assessment process, develop and implement quality systems such as CAPA, root cause analysis, and will develop performance improvement methods.Manages auditing follow-up activity. This position will work with the leadership team to develop strategic plans and policies for improved quality throughout the DCC to ensure compliance with regulatory agencies.
Leadership Commitment to Quality:
Promotes and inspires a culture of quality among all staff and faculty to integrate quality concepts into daily work.
Provides overall leadership to direct the design, build, implementation, maintenance, and evaluation of a Quality Management System (QMS) in the Data Coordinating Center.
Attends and facilitates DCC QI meetings, providing "expert" input regarding problem identification and resolution, continuous quality improvement (CQI), and other activities.
With Leadership input, prioritizes QMS activities for the DCC.
Provides guidance and direction to program directors and managers around quality goals and activities.
Work with directors and managers to integrate a quality component into the annual reviews of all DCC staff.
As part of the QMS system, defines quality metrics and develops criteria for evaluation. Develops appropriate data collection and analysis methods to support the system.
Risk Assessment and Mitigation:
Reviews DCC and Trial Innovation Center (TIC) studies to interpret risk assessment documents, site monitoring plans, data monitoring and statistical monitoring plans and other data sources used to assess quality care issues.
Issue Reporting and Management:
Creates reporting documents to use for tracking quality improvement (QI) activities, trends and patterns, and identifies opportunities for improvement.
Establishes and maintains an issue reporting system for tracking and follow up of issues.
Monitors daily quality control (QC), performs weekly and monthly QC, tracks and manages completion of vendor audits as needed.
Training and Education:
Provides education and training on implementation of QMS concepts and metrics for program directors, managers and program staff.
Standard Operating Procedures and Workflow Guidelines:
Reviews trending quality indicators. Writes and executes validation plans and SOPs, tracks deviation management, and preforms root cause analysis (RCA). Opens CAPAs as needed and follows to closure. Completes any other Quality Assurance (QA) duties as dictated by management.
Works with leadership, the Innovation Team, working groups, and staff to generate, execute, evaluate, and communicate quality initiative ideas and plans.
Requires a Bachelor’s degree in a related area of assignment or equivalency and 4 – 6 years of progressively more responsible management experience. Background knowledge of assigned department's area of specialization in order to analyze, plan and draw conclusions for recommendations to superiors. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop subordinates and to ensure the smooth operation of department.
Completion of provided supervisory training within one year of employment may be required.
Master's degree in a related area may be preferred. RAC and/or RQAP-GCP certification preferred
Internal Number: PRN18623B
About University of Utah
Data Coordinating Center - Pediatric Critical Care Research Network