Manager, Clinical Quality
About JAX-GM: Comprising 183,000 square feet of highly advanced, state-of-the-art laboratories and supporting facilities, the brand new JAX-GM conveniently sits midway between NYC and Boston in the heart of Connecticut. JAX-GM is part of an exciting $1.1 billion venture between the state of Connecticut and The Jackson Laboratory, an internationally-recognized research and educational institution with unparalleled genomic resources and research support services.
About the position: Reporting to the Associate General Manager, In Vivo & Clinical Services, the Clinical Quality Manager will have accountability for the quality program in the clinical genomics lab. Working with the Lab Director, the incumbent will manage the implementation and execution of the Quality Management Program governing the JGM clinical service (CLIA/CAP) offerings, ensuring successful external and internal audits. The incumbent will work closely with personnel at all levels of the organization, most notably the clinical laboratory director and staff of the clinical (CLIA) laboratory to achieve excellent and compliant service from the JGM clinical facility.
- Develop, Implement, and Maintain the JGM Clinical Quality Management program in accordance with all regulations to which the lab is subject (Federal, State, Accrediting Bodies, and International, when applicable).
- Evaluate compliance areas of clinical laboratory processes, lead gap and feasibility analyses to support growth of the clinical service (CLIA) offerings.
- Ensure continuing compliance and maintenance of licensure and accreditation, including licensure application, renewal, audit-readiness (internal and external), and test menu updates.
- Establish and maintain documented specifications for key regulatory standards including personnel qualifications and management, staff training and competency, laboratory proficiency testing, Standard Operating Procedures, test method validation/verification, test systems change control, selection of referral laboratories, and periodic document review.
- Work in concert with clinical laboratory staff to document, implement, and monitor new test development and validation in accordance with accreditation in a timely manner.
- Other duties as assigned, relevant to maintaining the overall quality and service offerings of the clinical genomics laboratory.
- Requires a Bachelor’s or Master’s Degree in Biology or related field with a minimum of 3 years of experience in laboratory quality systems and process control.
- Prior experience in a regulated environment (GCP, GLP or GMP), particularly in a clinical laboratory environment (CLIA/CAP accredited) leading process-centered initiatives (e.g. test development, validation, process improvement, and/or quality initiatives) and experience in the use of performance improvement tools and techniques.
- Ability to identify, trouble shoot/solve and document complex quality issues in compliance with all applicable regulations.
- Must have well developed interpersonal, organizational, and facilitation skills and be confident approaching, motivating, and communicating with personnel at all levels of The Jackson Laboratory organization.
- Proficient in Microsoft Office Suite, including Word, Excel, SharePoint, Outlook, and Access, with experience with project management software and maintenance and development of electronic databases preferred.
MORE ABOUT JAX
JAX began in 1929 with a small group of scientists dedicated to the emerging field of genetics. We now have over 1,700 scientists, technicians, and support staff, including over 50 Principle Investigators in five primary disease areas: cancer, reproductive biology, immunology, metabolic processes and neuroscience. Our fundamental contributions to biomedical research include cancer genetics and establishing the mouse as the premier research animal model.
- Uncover more of our historic milestones, including the 26 Nobel prizes associated with our research, resources, and education
- Read our latest news & insights for a glimpse at how we’re impacting the future of biomedicine
- Follow the progress we’re making on our quest to improve human health via our recent research highlights
EEO: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.