The Department of Pathology at Memorial Sloan Kettering Cancer Center has established the standard for whats possible in cancer diagnostics and care. A dedicated team of more than 650 team members spread across six laboratory services and nine campus locations, all focused on one goal: optimizing patient care by providing a precise and accurate diagnosis utilizing our state-of-the-art clinical laboratories and cutting-edge technologies. Our department consists of subspecialized pathologists, molecular diagnosticians, and researchers with expertise in a range of solid tumor types as well as hematopathology and cytopathology. As a team member of the Pathology Department, you have a unique opportunity to work with medical professionals and laboratory scientists highly distinguished in the field of cancer diagnosis. The contributions you will make to this team will have a positive and lasting effect on the patients we serve and the vital mission of Memorial Sloan Kettering Cancer Center.
We are seeking a Quality System and Regulatory Manager to join our team. You would be responsible for overseeing the Department of Pathology's quality and regulatory compliance programs (including, but not limited to Clinical Laboratory Improvement Amendments (CLIA), NYS Dept of Health Clinical Laboratory statute and regulations and Joint Commission (JC) accreditation standards) in collaboration with department managers, other institutional departments and institutional leadership. Responsibilities include continual assessment and reporting of department's degree of compliance with applicable requirements, identification of potential areas of compliance or quality vulnerability and addressing corrective action plans for resolution. The Quality and Regulatory manager will monitor performance of quality improvement and compliance initiatives on a continuing basis, taking appropriate steps to improve its effectiveness. The manager will provide consultation and training on related quality, regulatory and compliance topics.
Ensures continuous improvement of the laboratorys performance and services through ongoing monitoring that identifies, evaluates, and resolves problems.
Oversees the quality managers in the development, maintenance, and implementation of the departments and individual laboratories quality management programs.
Maintains current knowledge of federal, state, and local regulations that apply to the operation of a clinical laboratory, including proposed and final rules.
Communicates current and emerging quality management and regulatory information to Pathology laboratories
Manages communications to applicable regulatory agencies including filing of appropriate compliance reports.
Identifies quality and regulatory compliance issues that require follow-up or investigation
Reports significant quality, patient safety or regulatory compliance concerns to hospital and departmental leadership
Conducts and/or assists with investigations of reported complaints or identified allegation of regulatory violations.
Reports violation of compliance or regulatory standards to duly authorized enforcement agencies as appropriate and/or required.
Serves as departments liaison for quality and regulatory-related communications in collaboration with MSK Regulatory Affairs, the Division of Quality and Safety, and departmental leadership
Serves as the departments accreditation program manager, providing functional support as the departments liaison in dealing with regulatory bodies and accreditation agencies.
Masters Degree required
At least 10 years of experience in health care organization, to include demonstrated leadership required
Familiarity with operational, quality assurance, and federal, state, and local regulations and standards required
Internal Number: 2019-36382
About Memorial Sloan-Kettering Cancer Center
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.