Global Lab Director

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8mvbuf

- 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

La preghiamo di leggere attentamente la panoramica e i requisiti per questa occasione di lavoro riportati di seguito.

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 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 quali

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8mvbuf