Global Lab Director

4 giorni fa

Torino, Piemonte, Italia CTI Clinical Trial and Consulting Services Tempo pieno

Gratuito con email o Google

Salva questo lavoro e mantieni la tua ricerca organizzata

Crea un account gratuito per salvare lavori, creare avvisi e tornare a questa inserzione dalla tua dashboard.

Salva lavoro Salva e crea avviso

Gratuito con email o Google

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

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 quality control and quality assessment programs are established and maintained to assure the quality of services provided<

Global Lab Director

Salva questo lavoro e mantieni la tua ricerca organizzata

Lavoro simile a Torino

Offerte simili

Americhe

Europa

Asia / Oceania

Africa

Global Lab Director

Salva questo lavoro e mantieni la tua ricerca organizzata

Lavoro simile a Torino

Offerte simili