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 medicineLa preghiamo di leggere attentamente la panoramica e i requisiti per questa occasione di lavoro riportati di seguito.What 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, 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 LIMSPersonnel ManagementEnsure 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 Bring:Fluent in EnglishLocal requirements to serve as Laboratory Director in Bilbao, SpainLicense 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 testingMD or DO licensed to practice in the jurisdiction with board certifications in anatomic or clinical pathology, orMD 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 laboratoryAt least 5 years’ experience as a Clinical Laboratory leader with previous experience across multiple clinical disciplinesAbout CTIAdvance Your Career – We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.Important NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( ) or from our verified LinkedIn page. xysqume Please NoteWe will never communicate with you via Microsoft Teams or text messageWe will never ask for your bank account information at any point during the recruitment process#J-18808-LjbffrPer questa posizione sono disponibili opzioni di lavoro da remoto/a casa.

📌 Global Lab Director - Hybrid, Impactful Clinical Testing (Torino)
🏢 Cti Clinical Trial And Consulting Services
📍 Torino