Clinical Director, Laboratory Services (onsite Bilbao - Spain) - Level depending on experience

• 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

• 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

• 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.

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