Director Of Quality

Who is HealthTrackRx?HealthTrackRx is the nation's leading PCR-based infectious disease laboratory! By delivering next morning results to healthcare providers nationwide, HealthTrackRx is the premier option for patients and healthcare professionals and in an exciting phase of growthJob Summary:The Director of Quality will provide leadership and direction to the quality operations team overseeing clinical laboratory testing, the quality system of the laboratory and study execution. Responsible for activities related to Quality Department financial management, productivity, strategic planning, continuous improvement, staff development and management, procedures, and developing and implementing new services. Completes special assignments as assigned by the laboratory management team. Responsible ensuring that the laboratory meets quality and productivity standards and complies with all regulatory and safety standards as defined by CAP, JCAHO, CLIA, NYDOH, CA and OSHA.Essential Responsibilities/Duties: * Responsible for technical and quality oversight of laboratory operations and personnel performing pre-analytical, analytical, and post-analytical tasks as it relates to quality. * Leadership role within the lab QA department that assists with planning, implementing, and monitoring the Quality Management System (QMS). * Work closely with the Laboratory Director with technical and scientific oversight on standardizing the laboratory Quality systems for all sites under the administration of HealthtrackRx. * Ensure establishment and/or verification of laboratory test performance specifications and ensure they are maintained. * Monitor quality metrics: ensuring that remedial actions are taken, ensuring that patient results are not reported until corrective actions are taken, and test systems are functioning properly and in compliance. * Directs, coordinates, and oversees quality activities and projects to ensure that services are provided on schedule within quality and cost objectives. * Prioritize projects for HealthtrackRx based on the business needs * Collaborate with the laboratory managers on any issue that affects the quality, performance, scaling, etc. of HealthtrackRx. * Acts on operational issues with urgency to stay up to date on regulatory and compliance needs of the laboratory * Provide trouble-shooting expertise for out-of-control systems or tests when not immediately resolvable by the technologist or supervisor. * Direct implementation of possible process changes to improve quality, efficiency, and accuracy for the lab * Direct technologists in development of new methods through regular meetings and provides requirements and protocols for assessing validation acceptability. * Participates in technical development group efforts through interactive meetings and discussions that promote process improvements and technology developments. * Oversees test implementation as per compliance and regulatory requirements * Monitors ongoing test performance (Review of QC, PT, patient means)* Participate in selection of methodology and analytical techniques for performing clinical lab tests, taking into account accuracy, reliability, timeliness, cost, and technical difficulty. * Creates development and training plans for supervisory and lab personnel within the laboratory. * Assists with monitoring and responding to monthly volumes, utilization, financial, operational and quality metrics as needed. * Work collaboratively with and provide leadership to the other business units. * Participate in long-term planning for lab equipment and review with upper management. * Coordinates with IT and Supervisors to prioritize, validate and implement LIS changes to ensure accuracy of patient result reporting * Completes special assignments as assigned by the laboratory director or VP of lab operationsImplements and supports Quality Assurance Program and regulatory compliance: * Collaborate with Technical Supervisor and Laboratory Director for Quality Assurance updates, education, and updating/reviewing any CLIA regulations * Serves as an expert resource to the quality unit for all issues regarding licensure and compliance. * Ensures that all laboratory activities and operations are carried out in compliance with local state, federal, and governmental regulations, and laws. * Ensures documentation, correction, and follow-up of quality and safety events. * Participates in internal/external audits (CAP)* Identifies opportunities for improvement and utilizes continuous improvement methods in problem-solving to achieve desired outcomes.*

Verification, review, and/or assessment of the following documentation to confirm completion, accuracy, and an appropriate level of control, including, but not limited to, the following:*

Monthly QC;* Proficiency testing;* Study methods;* Validation and verification methods; and * Equipment, maintenance, and calibration records and service agreements. * Oversees troubleshooting and documentation of equipment, tests, results, etc.*

Verify quality control data from analyzers in all departments are appropriate and adheres to the laboratory's quality control policies on a monthly basis;* Ensure documentation of all quality control activities, instrument and procedural calibrations and maintenance performed on a monthly basis;* Participate and provide technical guidance on remedial actions whenever test systems deviate from the laboratory's established performance specifications: * Lead quality investigations to determine the root cause of non-conformances, initiating corrective and preventative actions and periodic checks to ensure established processes are maintained. * Assessment of technical data submitted by departments and preparation of report summaries. * Assist and provide guidance to technical staff performing new method validations, with recommendations on implementation strategies of new test methods and/or instruments for all test sites.Quality Program: * Lead and assist in the development/ongoing continuous quality management system for the laboratory under the guidance of Senior Management. Review monthly metrics for the laboratory and assist in corrective action/procedural changes to maintain "green light" status per desired/required goal(s). Participate in the local and national quality/safety committee meetings. Prepare the annual laboratory quality assessment plan that is evaluated for its effectiveness and assemble new initiatives planned by the Senior Management, Laboratory Director, and/or quality committee members. Work with the Technical Supervisor and IT to develop local and company-wide quality data.Process Improvement and Implementation: * Evaluate and assist with lean projects throughout the laboratory that improves overall processes to help the laboratory provide quality patient care in a cost effective and timely manner to its clients. * Develop an understanding of how sample preparation functions impact the workflow and result quality of the analytic department. * Assists with creation of quality training modules and processes within the laboratory. * Ensures adequate training of personnel including documentation of training.Provide leadership with complex test development and validation: * Provide analytical and clinical validation services for any methodologies requested for any physical site administered by HealthTrackRx * Design validation plans for complex or non-routine validations. * Ensure all test development meet the regulatory needs and review data to assist in troubleshooting and method validation. * Report validation summaries. * Write new and/or update SOPs and assist with training. * Assists with IT/IM planning for new tests. * Assists with planning for future test volumes including lab design, instrumentation, personnel, and quality systems. * Assists with laboratory information systems and software validations for all tests, review IT/IM planningSetup new satellite labs to meet the quality and regulatory requirements: * All instrumentation/platform and all sample matrices/collection devices will undergo vigorous validation to meet the CAP /NYDOH and CA regulatory needs for all physical site under the administration of HealthTrackRx * All validations will be accompanied by SOPs to govern the validation exercises as required by regulatory agencies, and a Summary Report upon conclusion of validation that includes performance metrics, clinical performance, and limited write-ups on Clinical Utility and Validity of the intended test, in an inspection friendly format * Provide mock inspection services at all physical sites administered by HealthTrackRx pursuant to obtaining/maintaining accreditation and/or certification status. * Drive DexCode registration and MolDx Technical Assessment submission, if requested a. Coverage determination by MolDx is not guaranteed for any TA submission. * Monitor and implement workflow automation/scaling at any site administered by HealthTrackRxQualifications: * Education -*

Master's degree or PhD in Biological sciences with at least 8+ years related experience and/or training in a commercial, clinical, environmental, analytical, or genetic laboratory environment,* Competencies/Skills -*

Ability to effectively communicate to various level stakeholders * High level of proficiency in Microsoft Word, Power Point, and Excel, required * Self-motivated and able to take ownership of projects and assignments * Ability to travel up to 50%* Experience -*

In depth knowledge of complex laboratory techniques, laboratory safety and quality assurance to support ongoing and future projects. * Experience in statistical data analysis, creation, and maintenance of policies and procedures, spreadsheets, chart and graphs, and data management