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.

The Pathology Department is searching for a new role to have a dedicated Quality Assurance (QA) Manager for FDA quality systems regulations as per FDA 21 CFR 820 and ISO 13485 standards.  The FDA QA Manager will be responsible for ensuring the Molecular Diagnostics CLIA laboratory meets FDA quality system standards, provide project management support for 510K and PMA applications, support quality investigations and inspections, and apply cGMP manufacturing documentation standards to Laboratory Developed Tests (LDTs).

You Will:

• Lead, develop, implement and monitor a FDA quality systems program in coordination with professional leadership, Administrator, Quality/Regulatory manager and Pathology QA committee.
• Develop, establish and maintain phase appropriate quality systems, policies, procedures and controls ensuring that the quality of LDTs conform to applicable regulatory requirements.  Ensure laboratory compliance with design controls, change controls, and record maintenance. 
• Works with technical directors and technical supervisors to determine resolution of operational or process problems that were observed during QA events, routine audits or external assessments. Evaluates situations/issues and advises supervisors, technical managers, and employees on how best to apply and enforce regulatory and laboratory/departmental quality standards.
• Provides administrative support to Quality & Regulatory Mgr by serving as laboratory's liaison in dealing with FDA regulatory and accreditation activities.
• Plan and manage audit programs (internal and external) using risk-based assessments, reporting findings/compliance metrics and implementing appropriate risk escalation and mitigation strategies
• Develops and administers in-service training programs for departmental personnel.  Maintains and enhances professional growth and development through seminars, workshops, and professional affiliations to keep abreast of trends in health care regulations and compliance.
• Provides guidance to technical directors, technical supervisors, and departmental leadership in compliance management and support for regulatory and accreditation standards interpretation.
• Makes recommendations to the department leadership regarding best quality management practices Molecular Diagnostics.

You Have:

• Bachelor’s Degree required
• Master’s degree preferred
• At least 5 years of Quality experience required in medical device industry
• Working knowledge, understanding and experience implementing 21 CFR 820, ISO 13485:2016, and ISO 14971 processes
• ASQ/CPHQ/LEAN Six Sigma training/certification preferred
• Experience working in a quality management role
• Strong compliance audit background
• Possess effective written and verbal communication, presentation, facilitation and project management skills

Hours:

• M-F, 9am-5pm

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Closing

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.