Sr. Laboratory Director

Foundation Medicine, Inc.

• Full Time

The Senior Laboratory Director (LD) is accountable for the overall operation and administration of a Foundation Medicine clinical laboratory site, including compliance with the applicable regulations, competence of lab personnel performing testing, and accuracy and timeliness of results to deliver excellent patient care and to support business needs. The Senior LD is a strong partner and collaborates with site leadership, particularly Laboratory Operations and Quality Assurance leaders, to ensure the laboratory is compliant with requirements of regulatory agencies, including CAP, CLIA, NYS, and ISO.

In addition to overseeing the clinical laboratory, this leadership role serves as a molecular and laboratory medicine subject matter expert to advise decision-makers within Foundation Medicine, including product development teams working with the FDA and external partners in support of the company's mission to transform cancer care. The Senior LD is responsible for the review and approval of various critical documentation, policies and reports, oversight of clinical testing strategies, assay(s) performance monitoring, and approving validations and verifications of new assays and assay modifications.

The Senior LD is supported by Section Directors within Pathology and Diagnostic Medicine.

• Site Senior (Medical) Laboratory Director and CLIA license holder accountable for all areas of laboratory clinical operations.
• In partnership with Lab Operations Site Head, Director of Quality Assurance Lab Operations, QA LabOPs Licensure & Accreditation team, and Lab Directors (LDs) and Operations Leadership at other sites, ensure laboratory compliance with all international, US federal and US state laws and regulations that govern the laboratory's operations (CLIA, NYS, and other state laboratory standards). This includes providing supervision of all testing personnel and reporting of test results and adherence to FDA requirements where applicable.
• Ensure compliance with clinical laboratory accreditation agency (CAP and ISO 15189) requirements and terms of accreditation, including participation in required inspections, audits and self-inspections.
• Communicate with laboratory regulatory and accrediting bodies as necessary and comply with regulatory and accrediting body requests for information in the event of an investigation.
• Ensure that the laboratory is appropriately staffed and resourced, in collaboration with Lab Operations Site Head and other functional leaders. Partner with operational and functional leaders to monitor and sustain resource levels necessary to sustain quality and safe laboratory operations.
• Ensure testing systems in the laboratory provide quality services in all aspects of test performance including how the results are reported out.
• In collaboration with Quality teams and site, Foundation Medicine LDs ensure the implementation of an effective Quality Management System, as well as ongoing monitoring and improvement of the system.
• Support assay validation/verification and optimization, as well as ongoing proficiency testing, alternative assessment and quality control procedures.
• Ensure that the laboratory participates in and compliantly completes all steps in an HHS approved proficiency testing program, as applicable.
• Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified and that patient test results are reported only when the system is functioning properly.
• Specify in writing the responsibilities and duties of each consultant and each person engaged in the performance of the pre-analytic, analytic and post-analytic phases of testing.
• Ensure that prior to testing patient specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.
• Provide initial and timely periodic review and approval of all required laboratory documents, including test validations, standard operating procedures, non-conformances, planned deviations, installation/operational qualifications, and other technical documentation.
• Ensure laboratory staff is appropriately educated, experienced, and/or trained and sufficient to properly supervise, perform and report test results and that documented procedures are followed.
• Develop and promote necessary operational performance levels aligned to regulatory requirements and corporate goals and objectives.
• Provide clinical expertise for corporate initiatives to modify existing tests, expand new testing capabilities. This includes involvement in the selection and monitoring of laboratory equipment, supplies and services, as well as the selection and monitoring of laboratory suppliers and referral laboratories.
• Provide…