06 set - Torino
Altro
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 have 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 p
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