Vai al contenuto principale

Senior Team Lead, IT & Digital Validation

The Role

The IT and Digital (IT&D) Validation Team Lead plays a central part in the quality assurance and acceptance of Genmab’s computer systems. As Senior Team Lead, you facilitate a strong connection between business stakeholders, the Quality Assurance department, and the IT&D department, and forges close cooperation between Genmab colleagues on many levels. 

The IT&D Validation Team Lead guides IT&D implementation projects and selected IT&D initiatives towards the level of qualification and validation that the projects and initiatives should cover and advises on the correct level of documentation. Genmab Quality Assurance is shifting from more traditional SDLC (Software Development Life Cycle) and CSV (Computer system Validation) to CSA (Computer Software Assurance), which demands a critical approach to documentation and testing. The validation expertise must be combined with a strong testing mindset.

This role will manage other external validation resources and maintain quality assurance procedures and processes to ensure that quality assurance is met for Genmab’s computer systems.

This new Team Lead will report directly to the Portfolio and Finance Tower Lead within IT&D.

 

Responsibilities

  • Responsible for bridging the Quality Assurance demands on IT&D Projects and initiatives by maintaining an IT&D Validation Framework with templates

  • Ensure external Validation Leads are working on the right deliverables at the right level of documentation towards a consistent validation package

  • Deliver according to Genmab’s Computerized system validation and software assurance SOP (Standard Operating Procedure)

  • Ensure timely communication and coordination of risks, activities, testing execution, and reporting

  • Ensure initiation/preparation and closeout of all validation related deviations, discrepancies, and change control documents

  • Provide recommendations for resolving deviations from established processes

  • Help project and product teams develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans

  • Coordinate project reviews of internal computer systems validation activities, protocol, and procedures, and prepare responses

  • Act as a Validation Lead for validation projects

  • Evaluate proposed changes to validated systems and recommend level of validation activities required, in close cooperation with IT QA

  • Support project management activities for validation projects

  • Assist with the development of system requirements and specifications to ensure requirements are testable and met

  • Execute or oversee the execution of validation plans and validation documents

  • Coach the implementation teams in the proper execution of validation documents

  • Preapprove test scripts before and after they are executed

  • Availability to travel (when appropriate)

 

Requirements

  • 10-12 years of experience in computer system validation and assurance, preferably in a biotech or pharmaceutical company

  • Good knowledge of quality management, including 21CFR Part 11 and GAMP

  • Results driven with a strong customer and quality focus

  • Hands on experience using Agile and Test Management applications

  • Multiple years of process improvement experience, especially experience that leverages technology as part of the solution

  • Hands-on experience with test modeling, analysis, and simulation tools

  • Experience working on projects using a variety of testing methods

  • Track record of working on projects that delivered different types of business outcomes

  • Ability to work on multiple projects concurrently with good organization skills

  • Business domain experience in the process areas being supported

  • Excellent interpersonal skills, verbal, and written communication, including great presentations

  • Strong analytical and conceptual skills

  • More interested in business results than personal preferences, and in group rather than individual achievement

  • Negotiating and networking, including conducting teambuilding activities

  • Being dynamic and self-motivated and thrive in working in a diverse environment

Degrees of interest: Computer system validation and assurance, preferably in a biotech or pharmaceutical company

Altre offerte di lavoro di 'WORKINDENMARK'

Director, IT Technical Architecture & DesignManager, System Change & Release ManagementUpstream Processing CMC SpecialistDownstream Processing CMC SpecialistAnalytical CMC SpecialistAssociate Director, Clinical Project LeadClinical Business Process ManagerMedical Writing ManagerSenior Manager, Medical Writing Document ManagementMedical DirectorSponsor Oversight LeadClinical Trial ManagerSenior Clinical Trial ManagerPrincipal/Senior BiostatisticianDirector, Team Lead, Trial ManagementActive Directory EngineerAnalytics & Visualization LeadBusiness Application Manager, CMCSenior Data EngineerAssociate Director, QA GCP/PVClinical Oversight Data Manager, BiometricsAssociate Director, Alliance ManagementSenior Clinical Research ScientistIAM EngineerCMC Project ManagerSenior Clinical Trial AssociateAssociate, Artwork and ComplianceSpecialist Stability OperationsCMC WriterSenior Manager, QA GMPStatistical ManagerSenior Manager / Associate Director, Clinical ProgrammingSenior Clinical Start Up ManagerResponsible Engineer for Expansion Projects, Process EngineeringOperational Maintenance EngineerElectrical EngineerManufacturing Project LeadAutomation EngineerContinuous Improvement Partner, QCDownstream Process EngineerPharmaceutical Quality System (PQS) SpecialistManufacturing ScientistLead for Quality DeviationsCMC Project DirectorExperienced Qualification and Validation Professionals for huge projectsProject Manager - PP Project OfficeAssociate Project AcademicLeaders to Associate Manager PipelineQuality Assurance ProfessionalDevelopment Scientist for API Manufacturing DevelopmentPostdoc in X-Ray MicroscopyPostdoc in Human Mucosal ImmunologyPhD scholarship in Enzyme Assisted CO2 CapturePhD Scholarship in Digital Phenotyping for Comorbid Mental HealthPhD position on Development of Digital Twins to Optimize Urban / Industrial Water Treatment SystemsSenior Commissioning & Operations Engineer for Cutting-Edge CO2 Capture and Utilization PlantsTravel-happy CO2 Capture TechnicianPostdoc in Biochemical Engineering or BiotechnologyDTU Tenure Track Researcher(s) in Organic Coatings TechnologyFermentation specialistPhD scholarship in Mucosal ImmunologyProcess Scientist and Process EngineersNewly graduated Engineers