A leading international scientific laboratory is seeking a Laboratory Director to lead its state-of-the-art facility in Bilbao

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, Integral 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:

Bachelor’s degree or higher in Medicine, Pharmacy, Chemistry, or a related clinical laboratory discipline
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

📌 Laboratory Director (Bilbao)
🏢 Hays
📍 Bilbao