Laboratory Quality Program Manager

About the role

The Laboratory Quality Program Manager serves at the health system level, ensuring compliance with applicable regulatory agencies governing clinical and anatomical pathology laboratories as well as all aspects of transfusion medicine (Blood Bank, Cellular Gene Therapy laboratory, Apheresis).

Responsibilities

• Create processes and systems to monitor quality data and performance.
• Recommend strategies to improve performance, safety and compliance.
• Work closely with the departments of Quality and Safety and Continuous Improvement.
• Attend applicable meetings and potentially present lab quality data results in various forums.
• Ensure procedures adhere to safety and compliance rules and regulations.
• Oversee compliance of Proficiency Testing, CAP standards, non-conforming events, procedure/policy and process review.
• Serve as the department representative during all audits/inspections, assisting auditors with any inquiries and reporting findings to management.
• Identify and monitor Key Performance Indicators (KPIs) for the lab.
• Communicate with lab and medical leadership when targets are not achieved.
• Establish the PI model to improve performance.
• Work collaboratively with laboratory leadership to implement, maintain and regularly review quality control programs.
• Identify and resolve technical problems ensuring appropriate remedial action is taken and documented whenever test systems deviate from established performance specifications.
• Work with the technical supervisors to devise streamlined competency documents for staff and hold accountability for the competency assessment program overall.
• Present quality metrics to leadership monthly and to the Quality and Safety forums, etc.
• Compile a CAP-compliant year-end summary of the overall quality management of the laboratories to be reviewed and approved by the Medical Director.
• Serve on relevant laboratory and organizational committees and work groups including the Quality and Safety Committees.
• Pursue knowledge of current and future advances in medical laboratory sciences and apply to the laboratory.

Requirements

• Bachelor's degree in Medical Technology or Health Sciences OR Bachelor’s degree in a chemical, physical or biological science with an Associate’s degree in Medical Laboratory Technology required.
• Minimum of 5 years’ experience in laboratory medicine, and one-year supervisory experience, such as a supervisor or Lead Tech required.
• Previous quality management experience preferred.
• MT(ASCP), MLS(ASCP), MT(AMT), or CLS(NCA), or equivalent certification required.
• ASQ or other quality certification preferred.
• Travel requirement - (30%) between both NCHFL & NCHDE Hospitals and other Nemours locations.