Laboratory Director
5 days ago
Bilbao
A leading international scientific laboratory is seeking a Laboratory Director to lead its state-of-the-art facility in Bilbao 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, • Personnel Management, • 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 to laboratory medicine What You'll Bring: • Bachelor’s degree or higher in Medicine, Pharmacy, Chemistry, or a related clinical laboratory discipline, • Fluent in English, • 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:, • PharmD or PhD 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