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New York Genome Center Compliance & Quality Systems Manager in New York, New York

Tracking Code

495-105

Job Description

We are looking for a highly motivated, independent but team-oriented Compliance & Quality Systems Manager. The Compliance & Quality Systems Manager is responsible for maintenance and oversight of day-to-day operations of the quality assurance/quality management program for New York Genome Center's (NYGC) clinical and production labs, which includes maintaining documents, records and certifications according to state and federal health care standards in compliance with accreditation guidelines. The position will also assist in quality and compliance tasks as needed across the organization. This role reports to the clinical lab director.

Job duties will include, but are not limited to:

Develop and maintain the NYGC clinical laboratory's quality management (QM) program in compliance with NYS CLEP and CAP standards;

Provide technical and analytical support for new assay validations and accreditation efforts;

Maintain QM documentation including but not limited to: assay validations, proficiency testing, vendor notifications, laboratory errors, and ongoing quality monitoring;

Perform root cause analysis and develop corrective and preventive action plans (CAPA) for deviations and nonconformities that may adversely affect test performance and/or patient care;

In collaboration with clinical laboratory management, monitor analytic performance and present performance data during monthly quality assurance (QA) meetings;

Implement process improvement initiatives under direction of the clinical laboratory director and production lab management;

Perform internal quality system audits and mock inspections to assess continued compliance and adherence to established policies and procedures;

Act as liaison to external auditors during regulatory audits and ensure action items are appropriately delegated and completed;

Stay up-to-date on applicable regulatory standards and checklists, advise clinical and production laboratory management on new requirements and other changes;

Establish and maintain document control and record retention systems for the clinical and production laboratories;

Assist clinical laboratory management with the selection, calibration, and maintenance of laboratory equipment and instrumentation;

Function as a liaison and point of contact between the clinical laboratory and other departments/individuals (both internal and external);

Maintain detailed personnel records including licensure, educational, and professional qualifications; training, competency assessments, and continuing education; performance reviews and records of disciplinary action;

Contribute to the development and improvement of standard operating procedures;

Perform other related duties as assigned to support departmental and organizational goals.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Required Experience

Bachelor's degree in genetics, biology, or related field required, MBA, MPH, or related graduate degree preferred;

5+ years of experience in a clinical laboratory environment required;

Must have experience with NYS Dept. of Health CLEP, CLIA, and CAP regulations for molecular testing;

Demonstrated understanding of molecular biology techniques required;

Excellent interpersonal, verbal, and written communication skills required;

Familiarity with Mac OS and Microsoft Office required;

Strong organizational and analytical skills required, including the ability to multitask and work effectively both independently and as part of a team;

Familiarity with Good Clinical Laboratory Practice (GCLP) preferred;

Valid New York Laboratory License (or eligible) preferred;

Experience managing quality initiatives preferred.

Competencies

Technical and Professional Skills: Consistently demonstrates skills and knowledge relevant for current role; strives to expand the depth and breadth of technical and professional skills; works with a high level of integrity; exhibits focus and discipline; appropriately prioritizes, manages expectations and delivers on commitments.

Collaborative & Communicative: Models collaboration and teamwork; brings out the best in others; effectively works with all levels, internally and externally; respects and embraces diversity of perspective; communicates clearly and listens carefully; uses good judgment as to what to communicate and when to do so.

Adaptable & Innovative: Adaptable and embraces change; develops new insights and pursues improvements and efficiency; fosters exchange of new ideas and willing to challenge the status quo; takes initiative and is solution-oriented; engages in work with passion and curiosity.

About the New York Genome Center

The New York Genome Center (NYGC) is an independent, nonprofit, academic research organization dedicated to advancing genomic research. NYGC scientists and staff are furthering new approaches to diagnosing and treating neurological diseases and cancer through their unique capabilities in whole genome sequencing, RNA sequencing, state-of-the art analytics, and the development of genomic tools. NYGC concentrates specifically on disease-based research in the following areas: neuropsychiatric disease (autism, schizophrenia, bipolar); neurodegenerative disease (ALS, Alzheimer's, Parkinson's, Huntington's), and cancer.

Located in Lower Manhattan, the New York Genome Center was founded by and remains closely affiliated with twelve leading academic medical centers and research universities in the New York region and beyond, engaging in research projects with and for these institutions. Essential to our collaborative work is an outstanding faculty, whose members typically hold a joint appointment at NYGC and a partner university. They support our scientific mission by conducting independent research in areas of mutual interest to us and the wider scientific community.

Clinical Lab: The NYGC has a state-of-the-art clinical diagnostic laboratory that utilizes next-generation sequencing technology to perform cutting-edge tests in the areas of genetics and oncology. The lab is accredited by the Clinical Laboratory Improvement Amendments (CLIA) and the Clinical Laboratory Evaluation Program of the New York State Department of Health (CLEP). It is licensed to perform clinical testing in all fifty (50) of the United States and the District of Columbia. The laboratory participates in the College of American Pathologists (CAP) proficiency testing.

Production Lab: The NYGC has a high-throughput next-generation sequencing lab and a robust analytics team capable of processing and analyzing over 50,000 human whole genomes per year. Our highly skilled and experienced laboratory staff ensures efficient processing of all research-based DNA and RNA sequencing projects. The laboratory tests and optimizes new processing protocols and instruments, works with the software engineering team to update and maintain the laboratory information management system (LIMS), and processes reagent orders and maintains up-to-date inventory with reporting to the finance department. All laboratory processes are highly automated and governed by standard operating procedures (SOPs) maintained and updated by the lab staff. The laboratory is GCLP compliant.

Equal Opportunity

Diversity, equity, and inclusion are central to the core mission at the NYGC. We strive to create a workplace environment that is welcoming and fair to all regardless of race, ethnicity, gender, sexual orientation, physical ability, or religion. We believe that when people of various backgrounds, life experiences, and perspectives work together in an inclusive and equitable environment we gain new and valuable perspectives that otherwise would have been missed. Valuing and supporting all NYGC employees as individuals while helping them realize their full potential is critical to promoting greater collaboration, innovation, and discovery - fostering a sense of belonging for our greatest strength, our people. We recognize that there is still work to be done that will require sustained commitment from the entire organization.

The New York Genome Center is a VEVRAA Federal Contractor. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, creed, color, gender, religion, national origin, sexual orientation, age, disability, genetic predisposition or carrier status, protected veteran or military status, domestic violence victim status, partnership status, caregiver status, alienage or citizenship status, marital status, or any other characteristic protected by applicable law. The New York Genome Center takes affirmative action in support of its policy to hire and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.

FLSA Status - Exempt

This position is not eligible for visa sponsorship or relocation assistance

Job Location

New York, New York, United States

Position Type

Full-Time/Regular

The New York Genome Center is a VEVRAA Federal Contractor. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability, or protected veteran status. The New York Genome Center takes affirmative action in support of its policy to and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.

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