Location: Basque Country
YOUR PURPOSE:
Responsible for providing effective clinical leadership for the development and delivery of global laboratory services and products of several labs located in Vizcaya ( Basque Country- Spain) . This position is responsible for clinical oversight of all laboratory operations, assuring that such operations are conducted in compliance with applicable regulations.
What You’ll Do:
Laboratory Oversight & Administrative
· Provide effective and efficient administrative direction of the laboratory.
· Ensure that qualified personnel are employed.
· Specify in writing the technical and administrative responsibilities and duties of all laboratory personnel.
· Ensure all technical staff has current and up to date licensing and credentials.
· Delegate the responsibilities of Laboratories.
· Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory test.
· 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.
· Participate in the selection of partner laboratories.
· Ensure that a supervisor provides onsite supervision of high complexity test performance.
· Act as operations representative for regulatory interactions.
· Oversee and maintain relevant laboratory testing and reporting, laboratory and clinical trial files and other laboratory documentation to ensure inspection readiness at times.
· Lead the development and continuous improvement .
· Review and approve laboratory documentation such as policies and procedures, validation plans and reports.
· Subject Matter Expert for client interactions and business development activities
· Report all concerns of test quality and/or safety to Vice President, Global Laboratory Services.
Laboratory Quality Management System (QMS)
Laboratory Information Management System (LIMS)
Personnel Management
Environment, Health & Safety
What You Bring
· A Medical Degree (MD) or Doctoral degree (PhD) in clinical laboratory science, pharma, chemical, physical, or biological science .
· 7-10 years’ experience as a Laboratory Director with administrative responsibilities and team management.
· Previous experience across multiple clinical disciplines.
· Must possess training and/or experience, obtained within the previous six years, in generally accepted and currently used methods and techniques in one or more categories listed below and must meet one of the following requirements:
Why this project?
· Career progression
· We value education and training.
· We value our people.
· Incredible culture.
· We think globally and act locally.
· We are looking toward the future .
· Our work makes a difference .