Associate Clinical Director, Laboratory Services (Bilbao)

What You'll Do:

• Laboratory Oversight & Administrative
  • Provide effective and efficient scientific direction and oversight for the CTI European Central Safety, Cellular and Molecular Laboratories
  • Ensure the development, implementation, and compliance of standardized processes for the CTI European Central Safety and Cellular Laboratories
  • Ensure that technical staff are qualified to perform all testing and has met training and/or competency requirements
  • Ensure all technical staff has current and up to date licensing and/or credentials
  • Delegate the responsibilities of the Laboratory Supervisor, Specialty Laboratory Directors/Supervisors, Quality Control Manager and Testing Personnel to employees who are qualified to perform such duties
  • 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 and ensure that reports of test results include pertinent information required for specific patient/subject interpretation
  • Subject Matter Expert for client interactions and business development activities
  • Ensure that a supervisor provides onsite supervision of high complexity test performance
  • Act as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR, etc
  • Oversee and maintain relevant laboratory testing and reporting, laboratory and clinical trial files and other laboratory documentation to ensure inspection readiness at all times
  • Lead the development and continuous improvement of laboratory SOPs, and GLPs and provide oversight of laboratory quality & 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 reagent/control/instrument qualifications, quality audits, deviation approval requests, and nonconforming event reports
  • Maintain an effective working relationship with applicable accrediting and regulatory agencies
  • 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 including management of outcomes and non-conformities, participation in internal quality control system monitoring, and performance in proficiency testing
  • Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of Clinical Laboratory Services provided and to identify failures in quality as they occur
  • Ensure that the laboratory participates in monitoring and evaluating the quality assurance program by adhering to required regulatory activities, within the context of the Quality Management System, regardless of where the testing is performed
  • Ensure that the laboratory is enrolled in the appropriate proficiency testing program for the testing performed
  • Effectively implement corrective action plans to deficiencies identified
  • Perform and document monthly quality audits of all testing equipment to ensure optimal accuracy and performance
• Laboratory Information Management System (LIMS)
  • Work with the IT Manager and Lab Leadership Team 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
  • Ensure that an approved procedure manual is available to all personnel

 

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 @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

 

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