Descripción de la oferta
Under the direction and mentorship of our Clinical Director, Global Laboratory Services, this position is responsible for providing effective clinical leadership for the development and delivery of global laboratory services and products.Dé el siguiente paso en su carrera profesional ahora: desplácese hacia abajo para leer la descripción completa del puesto y envíe su solicitud.This position is responsible for clinical oversight of all European safety and flow cytometry laboratory operations, assuring that such operations are conducted in compliance with applicable regulations.What You'll Do Laboratory Oversight & Administrative Provide effective and efficient scientific direction and oversight for the Bilbao laboratory safety and specialty testing (hematology, chemistry, immunoassays, flow cytometry, molecular...) Ensure the development, implementation, and compliance of standardized processes for CTI central lab Ensure that technical staff are qualified, and licensed as required, to perform and supervise all testing and has met training and/or competency requirements Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory tests Monitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reported Provide advice to sponsors and clients regarding the significance of laboratory findings Subject Matter Expert for client interactions and business development activities Act as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR, etc Oversee and maintain relevant laboratory documentation to ensure inspection readiness Lead the development and continuous improvement of laboratory quality system and ensure adherence to established processes and plans Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments and nonconforming event reports Participate in the selection of partner laboratories Report all concerns of test quality and/or safety to Clinical Director, Global Laboratory Services Laboratory Quality Management System (QMS) Working with Quality Assurance to support and enforce all aspects of the laboratory's QMS to ensure conformance to requirements described in the Quality Management System and Clinical Laboratory Practice Standards Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of services provided Ensure that the laboratory participates in monitoring and evaluating the quality assurance program by adhering to required regulatory activities Ensure that the laboratory is enrolled in the appropriate proficiency testing program for the testing performed Effectively implement corrective action plans to deficiencies identified Laboratory Information Management System (LIMS) Work with IT and Lab Leadership in implementation and management of the LIMS Ensure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills Provide continuing education to laboratory technical staff that is relevant xcskxlj to laboratory medicine What You'll Bring Local requirements to serve as Laboratory Director in Bilbao, Spain License requirements to serve as a CAP (College of American Pathologists) laboratory director for international labs: Pharm D or Ph D in a chemical, biological, or clinical laboratory science with specialization in Clinical Analysis (Análisis Clínicos) or Clinical Biochemistry (Bioquímica Clínica), or EU equivalent (e.g Clinical Biologist), recognized by the Spanish Ministry of Health, AND 2 years of clinical laboratory experience directing/supervising high complexity testing MD or DO licensed to practice in the jurisdiction with board certifications in anatomic or clinical pathology, or MD or DO licensed to practice in the jurisdiction with 1 year clinical laboratory training during residency or 2 years of experience supervising high complexity testing in a clinical laboratory At least 5 years' experience as a Clinical Laboratory leader with previous experience across multiple clinical disciplines #J-18808-Ljbffr
