More jobs:
Digital Quality Lead
Job in
Town of Belgium, Belgium, Ozaukee County, Wisconsin, 53004, USA
Listed on 2026-06-23
Listing for:
MSI Pharma
Full Time
position Listed on 2026-06-23
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist -
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Location:Walloon Region(hybridworkingmodel)
Engagement:12-monthfreelanceengagement(ASAPstart)
OverviewWearepartneredwithaglobalpharmaceuticalorganisationtosupportthebuild-outoftheir
QualityR&D&Pharmacovigilancefunction.
Thisisanewlycreated
BusinessQArolefocusedonoversightof Gx Pcomputerizedsystems ,withaparticularemphasison
Computerized System Validation (CSV) andDataIntegrity.
Thepositionsitsattheintersectionof Quality,IT,andbusinessteams,ensuringsystemsarecompliant,fitforpurpose,andalignedwithregulatoryexpectations.
- ProvideQAoversightof Gx Psystemsacross GCP,GLP,andPVenvironments
- ReviewandcontributetoCSVdeliverables(risk assessments,validation documentation,DI assessments)
- Supportthefullsystemlifecycle,fromselectionandonboardingthroughtovalidationandongoingcompliance
- PartnerwithIT,QA,andbusinessstakeholderstoalignsystemusagewithregulatoryrequirements
- Assessandmitigatedataintegrityrisks,ensuringappropriatecontrolsareimplemented
- Contributetoinvestigations,deviations,CAPAs,and inspection-readiness activities
- Provenexperiencein Computerized System Validation (CSV)
- BackgroundinGCPand/or Pharmacovigilanceenvironments
- PriorexperiencewithinpharmaceuticalR&D
- Strongknowledgeof Gx Pframeworks (GLP,GCP,GVP)
- Solidunderstandingof Data Integrity principles (ALCOA+,datalifecycle,audit trails)
- Fluentin English
- Abilitytoworkautonomouslyandmanagemultiplestakeholders
- Strongcriticalthinkingandproblem-solving capability
- Confident communicator,abletobridgetechnicalandbusinessteams
- Detail-orientedwithacompliance-first mindset
- Approx.
3–5years’relevant experience(mediorlevel) - Degreeinascientificorrelateddiscipline(Master’spreferred)
- Experiencedworkingincross-functional,regulated environments
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