Pathology Quality System and Regulatory Manager

Company Overview

At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.
For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.

Job Description

We Are:


The Department of Pathology at Memorial Sloan Kettering Cancer Center has established the standard for what’s 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.


You Will:

  • Ensures continuous improvement of the laboratory’s performance and services through ongoing monitoring that identifies, evaluates, and resolves problems.
  • Oversees the quality managers in the development, maintenance, and implementation of the department’s 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.
  • Manages department’s regulatory survey readiness strategies.
  • 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 department’s 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 department’s accreditation program manager, providing functional support as the department’s liaison in dealing with regulatory bodies and accreditation agencies.


You Have:

  • Master’s 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


MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.  


Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.


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