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, General 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