20 set - Torino
Altro
Provide effective and efficient scientific direction and oversight for the Bilbao laboratory safety and specialty testing (hematology, chemistry, immunoassays, flow cytometry, molecular…)
È questo il suo prossimo lavoro? Legga la descrizione completa qui sotto per scoprirlo e non esiti a candidarsi.
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
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
Personnel Management
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 Bring
Fluent in English
Local requirements to serve as Laboratory Director in Bilbao, Spain
License 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 testing
MD or DO licensed to practice in the jurisdiction with board certifications in anatomic or clinical pathology, or
MD 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 laboratory
At least 5 years’ experience as a Clinical Laboratory leader with previous experience across multiple clinical disciplines
About CTI
Advance 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 Note In 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. xkiyazw
Please Note
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process
Per questa posizione sono disponibili opzioni di lavoro a distanza/a casa.
21 set - Milano
Simcorp
21 set - Macerata
Adecco Italia
21 set - Pavia
Ams Italy
21 set - Milano
ICRI