Manager, Clinical Laboratory

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Phoenix, AZ location supporting Molecular Diagnostics in our Cancer Diagnostics division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions.  We help people live full and healthy lives through our accessible, molecular-based solutions. The Manager, Clinical Laboratory manages the overall daily clinical laboratory operations and develops procedures to ensure safety, quality, and accuracy of results. This position oversees the supervision and development of laboratory staff, provides technical expertise to the laboratory, and serves as the liaison to internal and external entities. In addition, the Manager, Clinical Laboratory oversees the quality management program within the clinical laboratory and ensures that the laboratory is in compliance with all laws and regulations required by CLIA, CAP, OSHA, New York, and any other applicable state or federal legislative organizations. The Manager, Clinical Laboratory collaborates with various departments and cross-functional teams to ensure the quality and timeliness with which patient and clinical validation study samples are processed, and is accountable for the laboratory team’s deliverables on designated product development and process development projects. The Manager, Clinical Laboratory facilitates timely and effective communication with other departments regarding service coverage needs and resolution of issues related to commercial patient samples, adjusting laboratory staffing levels, as needed. The Manager, Clinical Laboratory may perform high complexity laboratory testing on patient specimens, interprets and reports patient results, and troubleshoots high complexity technical and non-technical problems. What You’ll Work On • Directs the daily workflow of the clinical laboratory departments; including, but not limited to, ensuring processing systems for patient and study samples are functioning properly, monitoring quality control testing results, and monitoring quality assurance performance metrics. • Manages designated laboratory and cross-functional projects such as process improvements, quality improvements, clinical validation studies, and the development and launch of new products. • Collaborates with Exact Sciences’ human resources department and participates in the employee hiring and management process by interviewing candidates, hiring, and employee counseling. • Assesses scheduling needs of the departments to ensure adequate coverage to meet service needs. • Identifies and understands regulatory requirements to ensure that the laboratory complies with all applicable state and federal laws and regulations pertinent to the management of the laboratory; including applicable CLIA, CAP, and other requirements and regulations such as California and New York (CLEP) laboratory programs. • Manages the inspection preparation activities in the clinical laboratory, such as maintaining consistent, ongoing readiness for inspections and representing the clinical laboratory during inspections. • Provides or delegates responsibility of supervision of the clinical laboratories and is accessible to the laboratory personnel to provide on-site, telephone, or electronic consultation. • Maintains a process for staffing, recruiting, training, evaluating competency, and ongoing employee development. • Works strategically with department supervisors and managers to ensure testing is completed within turnaround time. • Partners with senior management in establishing strategic priorities and annual quality indicators. • Collaborates with the laboratory leadership to assist in developing and providing continuing education credits for the laboratory staff. • Ensures staff are properly trained and competent in all aspects of their job duties and departmental procedures. • Reviews, writes, and updates standard operating procedures (SOPs). • Reviews and writes nonconformance and deviation approval requests, and other documents, as appropriate. • Possesses effective management skills to supervise department staff and maintain departmental budgets. • Provides oversight to ensure prompt, accurate, and timely processing, and delivery of all patient specimens. • Evaluates equipment and supply needs of the laboratory. • Works with the laboratory leadership to maintain operations within the budget. • Assures timely and appropriate ordering of supplies and equipment. • Partners with the laboratory supervisors to monitor supply usage and variances. • Reviews test volumes with laboratory leadership to develop and implement timely changes to manage workload. • Verifies test procedures performed, and with assistance, establish the laboratory’s test performance characteristics, including precision and accuracy of each test and test system. • Ensures that the quality management program is maintained by following parameters for acceptable performance for the pre-analytical, analytical, and post-analytical testing processes. • Resolves high complexity technical problems, with the aid of the technical staff and ensures that remedial action is taken whenever a test deviates from the laboratory’s performance standards. • Ensures that all patient results are not reported until corrective actions have been taken and the systems are functioning properly. • Identifies training needs and ensures all training is performed, as required. • Assists with the training of new laboratory personnel and training of new procedures with existing personnel, as needed. • Evaluates competency of all laboratory personnel. • Supervises staff; including, but not limited to, organize and prioritize work, write/conduct p