Global Lab Director

ulliProvide effective and efficient scientific direction and oversight for the Bilbao laboratory safety and specialty testing (hematology, chemistry, immunoassays, flow cytometry, molecular…) /liliEnsure the development, implementation, and compliance of standardized processes for CTI central lab /liliEnsure that technical staff are qualified, and licensed as required, to perform and supervise all testing and has met training and/or competency requirements /liliResponsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory tests /liliMonitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reported /liliProvide advice to sponsors and clients regarding the significance of laboratory findings /liliSubject Matter Expert for client interactions and business development activities /liliAct as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR, etc /liliOversee and maintain relevant laboratory documentation to ensure inspection readiness /liliLead the development and continuous improvement of laboratory quality system and ensure adherence to established processes and plans /liliReview and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments and nonconforming event reports /liliParticipate in the selection of partner laboratories /liliReport all concerns of test quality and/or safety to Clinical Director, Global Laboratory Services /liliLaboratory Quality Management System (QMS) /liliWorking 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 /liliEnsure that the quality control and quality assessment programs are established and maintained to assure the quality of services provided /liliEnsure that the laboratory participates in monitoring and evaluating the quality assurance program by adhering to required regulatory activities /liliEnsure that the laboratory is enrolled in the appropriate proficiency testing program for the testing performed /liliEffectively implement corrective action plans to deficiencies identified /liliLaboratory Information Management System (LIMS) /liliWork with IT and Lab Leadership in implementation and management of the LIMS /liliEnsure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills /liliProvide continuing education to laboratory technical staff that is relevant to laboratory medicinebr/li /ulstrongWhat You'll Do: /strongbrulliLaboratory Oversight Administrative /liulliProvide effective and efficient scientific direction and oversight for the Bilbao laboratory safety and specialty testing (hematology, chemistry, immunoassays, flow cytometry, molecular…) /liliEnsure the development, implementation, and compliance of standardized processes for CTI central lab /liliEnsure that technical staff are qualified, and licensed as required, to perform and supervise all testing and has met training and/or competency requirements /liliResponsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory tests /liliMonitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reported /liliProvide advice to sponsors and clients regarding the significance of laboratory findings /liliSubject Matter Expert for client interactions and business development activities /liliAct as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR, etc /liliOversee and maintain relevant laboratory documentation to ensure inspection readiness /liliLead the development and continuous improvement of laboratory quality system and ensure adherence to established processes and plans /liliReview and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments and nonconforming event reports /liliParticipate in the selection of partner laboratories /liliReport all concerns of test quality and/or safety to Clinical Director, Global Laboratory Services /li /ulliLaboratory Quality Management System (QMS) /liulliWorking 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 /liliEnsure that the quality control and quality assessment programs are established and maintained to assure the quality of services provided /liliEnsure that the laboratory participates in monitoring and evaluating the quality assurance program by adhering to required regulatory activitie