Digital Quality Lead

MSI Pharma; Town of Belgium (WI); Hybrid; USD 80,000 - 100,000; Full time

Job summary

MSI Pharma is seeking a Quality Assurance professional for a 12-month freelance engagement based in Belgium. This position involves overseeing GxP computerized systems with a focus on Computerized System Validation (CSV) and Data Integrity.

The ideal candidate will have 3-5 years of relevant experience and a degree in a scientific discipline. Responsibilities include providing QA oversight, supporting the system lifecycle, and working cross-functionally with IT and business teams.

Qualifications

• 3-5 years of relevant experience at a medior level.
• Experience in cross-functional, regulated environments.

Responsibilities

• Provide QA oversight of GxP systems across GCP, GLP, and PV environments.
• Review and contribute to CSV deliverables.
• Support the full system lifecycle.
• Partner with IT, QA, and business stakeholders.
• Assess and mitigate data integrity risks.

Skills

Computerized System Validation (CSV)

GxP knowledge

Background in GCP and/or Pharmacovigilance

Data Integrity principles (ALCOA+)

Fluent in English

Education

Degree in a scientific or related discipline

Job description

Location:WalloonRegion(hybridworkingmodel)

Engagement:12-monthfreelanceengagement(ASAPstart)

Overview

Wearepartneredwithaglobalpharmaceuticalorganisationtosupportthebuild-outoftheirQualityR&D&Pharmacovigilancefunction.ThisisanewlycreatedBusinessQArolefocusedonoversightofGxPcomputerizedsystems,withaparticularemphasisonComputerizedSystemValidation(CSV)andDataIntegrity.ThepositionsitsattheintersectionofQuality,IT,andbusinessteams,ensuringsystemsarecompliant,fitforpurpose,andalignedwithregulatoryexpectations.

Responsibilities

• ProvideQAoversightofGxPsystemsacrossGCP,GLP,andPVenvironments
• ReviewandcontributetoCSVdeliverables(riskassessments,validationdocumentation,DIassessments)
• Supportthefullsystemlifecycle,fromselectionandonboardingthroughtovalidationandongoingcompliance
• PartnerwithIT,QA,andbusinessstakeholderstoalignsystemusagewithregulatoryrequirements
• Assessandmitigatedataintegrityrisks,ensuringappropriatecontrolsareimplemented
• Contributetoinvestigations,deviations,CAPAs,andinspection-readinessactivities

HardSkills

• ProvenexperienceinComputerizedSystemValidation(CSV)
• BackgroundinGCPand/orPharmacovigilanceenvironments
• PriorexperiencewithinpharmaceuticalR&D
• StrongknowledgeofGxPframeworks(GLP,GCP,GVP)
• SolidunderstandingofDataIntegrityprinciples(ALCOA+,datalifecycle,audittrails)
• FluentinEnglish

SoftSkills

• Abilitytoworkautonomouslyandmanagemultiplestakeholders
• Strongcriticalthinkingandproblem-solvingcapability
• Confidentcommunicator,abletobridgetechnicalandbusinessteams
• Detail-orientedwithacompliance-firstmindset

Qualifications

• Approx.3–5years’relevantexperience(mediorlevel)
• Degreeinascientificorrelateddiscipline(Master’spreferred)
• Experiencedworkingincross-functional,regulatedenvironments