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Digital Quality Lead

Job in Town of Belgium, Belgium, Ozaukee County, Wisconsin, 53004, USA
Listing for: MSI Pharma
Full Time position
Listed on 2026-10-07
Job specializations:
  • Quality Assurance - QA/QC
    QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below
Location: Town of Belgium

Location:Walloon Region(hybridworkingmodel)

Engagement:12-monthfreelanceengagement(ASAPstart)

Overview

Wearepartneredwithaglobalpharmaceuticalorganisationtosupportthebuild-outoftheir

QualityR&D&Pharmacovigilancefunction.

Thisisanewlycreated

BusinessQArolefocusedonoversightof Gx Pcomputerizedsystems ,withaparticularemphasison

Computerized System Validation (CSV) andDataIntegrity.

Thepositionsitsattheintersectionof Quality,IT,andbusinessteams,ensuringsystemsarecompliant,fitforpurpose,andalignedwithregulatoryexpectations.

Responsibilities
  • ProvideQAoversightof Gx Psystemsacross GCP,GLP,andPVenvironments
  • ReviewandcontributetoCSVdeliverables(risk assessments,validationdocumentation,DIassessments)
  • Supportthefullsystemlifecycle,fromselectionandonboardingthroughtovalidationandongoingcompliance
  • PartnerwithIT,QA,andbusinessstakeholderstoalignsystemusagewithregulatoryrequirements
  • Assessandmitigatedataintegrityrisks,ensuringappropriatecontrolsareimplemented
  • Contributetoinvestigations,deviations,CAPAs,and inspection-readiness activities
Hard Skills
  • Provenexperiencein Computerized System Validation (CSV)
  • BackgroundinGCPand/or Pharmacovigilanceenvironments
  • PriorexperiencewithinpharmaceuticalR&D
  • Strongknowledgeof Gx Pframeworks (GLP,GCP,GVP)
  • Solidunderstandingof Data Integrityprinciples (ALCOA+,datalifecycle,audit trails)
  • Fluentin English
Soft Skills
  • Abilitytoworkautonomouslyandmanagemultiplestakeholders
  • Strongcriticalthinkingandproblem-solving capability
  • Confident communicator,abletobridgetechnicalandbusinessteams
  • Detail-orientedwithacompliance-first mindset
Qualifications
  • Approx.
    3–5years’relevant experience(mediorlevel)
  • Degreeinascientificorrelateddiscipline(Master’spreferred)
  • Experiencedworkingincross-functional,regulated environments

We would love to welcome a new Digital Quality Lead to our organisation in Town of Belgium, WI, United States.

Take a moment to read everything above and see whether this role is right for you.

This posting is for the Digital Quality Lead role at MSI Pharma, based in Town of Belgium, WI, United States.

We are looking to fill the Digital Quality Lead position at MSI Pharma in Town of Belgium, WI, United States.

The Digital Quality Lead role at MSI Pharma is now open for applications in Town of Belgium, WI, United States.

Join us at MSI Pharma as our next Digital Quality Lead in Town of Belgium, WI, United States.

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