* 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 to laboratory medicine Asegúrese de leer la descripción completa a continuación y, si confía en que cumple todos los requisitos, envíe su solicitud de inmediato.

What You'll Do
* Laboratory Oversight & Administrative o Provide effective and efficient scientific direction and oversight for the Bilbao laboratory safety and specialty testing (hematology, chemistry, immunoassays, flow cytometry, molecular...) o Ensure the development, implementation, and compliance of standardized processes for CTI central lab o Ensure that technical staff are qualified, and licensed as required,



to perform and supervise all testing and has met training and/or competency requirements o Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory tests o Monitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reported o Provide advice to sponsors and clients regarding the significance of laboratory findings o Subject Matter Expert for client interactions and business development activities o Act as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR, etc o Oversee and maintain relevant laboratory documentation to ensure inspection readiness o Lead the development and continuous improvement of laboratory quality system and ensure adherence to established processes and plans o Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments and nonconforming event reports o Participate in the selection of partner laboratories o Report all concerns of test quality and/or safety to Clinical Director, Integral Laboratory Services
* Laboratory Quality Management System (QMS) o 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 o Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of services provided o Ensure that the laboratory participates in monitoring and evaluating the quality assurance program by adhering to required regulatory activities o Ens

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