Digital Specialist
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DigitalSpecialist–AnalyticalDevelopment Location: Brainel'Alleud,BelgiumEngagementStatus: FreelancepositionuntilendofDecember2026(strongpotentialextension)Overview WearesupportingalargepharmaceuticalorganisationwhoarelookingforaDigitalSpecialist– AnalyticalDevelopmenttosupportamajordigitaltransformationwithinanAnalyticalDevelopmentSciencesenvironment,partofCMC.Thisrolesitsattheintersectionofanalyticallaboratories,digitalsolutions,andregulatorycompliance,supportinganalyticalmethoddevelopmentandstabilityactivitiesfromearlyclinicalphasesthroughlifecyclemanagement.TheenvironmentspansbothGSPandGMP.Thepositionisembeddedinalarge-scaledigitaltransformationprogramdrivenbyFDAdigitalsubmissionrequirements,withastrongfocusonstructured,traceable,andregulatory‑readyanalyticaldata.KeyResponsibilities
- Actasabridgebetweenanalyticaldevelopmentscientists,quality,IT,anddigitalteams
- Analyzeexistinglaboratoryprocessesanddataflows
- Performend‑to‑endprocessanddatamapping
- Translatescientificandbusinessprocessesintostructureddatarequirements
- ChallengeITanddigitalsolutionsfromabusinessanduserperspective
- Ensurecompliancebydesign(GxP,ALCOA+)
- Supportdeploymentofdigitaltoolsandassistendusers
- Facilitatediscussionsbetweenstakeholdersanddrivepragmatic,alignedsolutions
- 3–8yearsofprofessionalexperience
- Provenexperienceindatamapping,dataflowdesign,businessanalysis,ordataanalysis
- StrongunderstandingofGxPenvironmentsandALCOA+principles
- ExperienceworkingattheinterfacebetweenbusinessandIT
- FluentEnglish(mandatory)
- Translatinglaboratoryworkflowsintostructureddigitalanddatarequirements
- Processmappinganddataflowdesign
- Regulatoryandcompliance‑drivendigitalsolutions
- Experiencewithregulatedenvironments(GxP)
- Nicetohave:
- CMC,AnalyticalDevelopment,orQClaboratoryexposure
- ELN(e.g.IDBS),LIMS(e.g.LabWare),PowerBI
- Datagovernanceordataengineeringconcepts
- Experienceindigitaltransformationprograms
- Strongstakeholdermanagementandcommunicationskills
- Business‑orientedmindsetwiththeabilitytochallengeconstructively
- Abilitytostructurecomplexdiscussionsandaligndiversestakeholders
- Pragmatic,solution‑drivenapproach
- Comfortableworkingincross‑functional,internationalenvironments