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 labEnsure that technical staff are qualified, and licensed as required, to perform and supervise all testing and has met training and/or competency requirementsResponsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory testsMonitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reportedProvide advice to sponsors and clients regarding the significance of laboratory findingsSubject Matter Expert for client interactions and business development activitiesAct as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR, etcOversee and maintain relevant laboratory documentation to ensure inspection readinessLead the development and continuous improvement of laboratory quality system and ensure adherence to established processes and plansReview and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments and nonconforming event reportsParticipate in the selection of partner laboratoriesReport all concerns of test quality and/or safety to Clinical Director,



Global Laboratory ServicesLaboratory 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 StandardsEnsure that the quality control and quality assessment programs are established and maintained to assure the quality of services providedEnsure that the laboratory participates in monitoring and evaluating the quality assurance program by adhering to required regulatory activitiesEnsure that the laboratory is enrolled in the appropriate proficiency testing program for the testing performedEffectively implement corrective action plans to deficiencies identifiedLaboratory Information Management System (LIMS)Work with IT and Lab Leadership in implementation and management of the LIMSEnsure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skillsProvide continuing education to laboratory technical staff that is relevant to laboratory medicineWhat You'll Do:Laboratory Oversight & AdministrativeProvide 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 labEnsure that technical staff are qualified, and licensed as required, to perform and supervise all testing and has met training and/or competency requirementsResponsible for designing, validating,



and maintaining the technical accuracy and medical reliability of the laboratory testsMonitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reportedProvide advice to sponsors and clients regarding the significance of laboratory findingsSubject Matter Expert for client interactions and business development activitiesAct as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR, etcOversee and maintain relevant laboratory documentation to ensure inspection readinessLead the development and continuous improvement of laboratory quality system and ensure adherence to established processes and plansReview and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments and nonconforming event reportsParticipate in the selection of partner laboratoriesReport all concerns of test quality and/or safety to Clinical Director, General Laboratory ServicesLaboratory 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 StandardsEnsure that the quality control and quality assessment programs are established and maintained to assure the quality of services providedEnsure that the laboratory participates in monitoring and evaluating the quality assurance program by adhering to required regulatory activitiesEnsure that the laboratory is enrolled in the appropriate proficiency testing program for the testing performedEffectively implement corrective action plans to deficiencies identifiedLaboratory Information Management System (LIMS)Work with IT and Lab Leadership in impleme

📌 Global Lab Director (País Vasco)
🏢 Cti Clinical Trial And Consulting Services
📍 País Vasco