WhatYou’llDo:
Desplácese hacia abajo para ver todos los requisitos del puesto y las responsabilidades que pueden esperar los candidatos seleccionados.

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- Laboratory Oversight & Administrative

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- 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)

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- 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)

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- Work with IT and Lab Leadership in implementation and management of the LIMS

- Personnel Management

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- 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

WhatYou’llBring:

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- 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:

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- 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

AboutCTI

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- AdvanceYourCareer –Weinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals.

- JoinanAward-WinningTeam –Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram,you’llhaveopportunitiestogivebacktoyourcommunityandtheworld.

- MakeaLastingImpact –AtCTI,yourworkdirectlycontributestoadvancingmedicine.You’llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses. xhfqzwm Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost.

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📌 Clinical Director, Laboratory Services (Onsite Bilbao - Spain) - Level Depending On Experience
🏢 Cti
📍 Bilbao