QC Systems Integration Consultant (GMP Laboratory Systems)
About The RoleWe are seeking an experienced QC Systems Integration Consultant to support a large-scale migration and consolidation program across multiple GMP regulated Quality Control laboratory systems. This role is focused on the end to end implementation, integration coordination, and validation support of a complex laboratory IT and instrument landscape, ensuring compliant deployment and successful operational readiness.The consultant will play a critical role in managing system onboarding, coordinating technical and business stakeholders, overseeing implementation progress, and supporting validation activities in close collaboration with QA and laboratory teams.Key ResponsibilitiesLead implementation kick off activities for multiple QC laboratory systems within a GMP regulated environmentCoordinate and oversee end to end system integrations across laboratory instruments, software applications, and enterprise platformsManage project execution against agreed scope, timeline, budget, and quality objectivesDrive alignment between laboratory operations, IT, vendors, QA, and validation stakeholdersMonitor implementation progress, identify risks, and proactively resolve integration issuesSupport data migration and system consolidation activities across legacy and target platformsEnsure proper documentation and compliance with internal CSV / CSA and GxP requirementsSupport QA and validation teams during IQ / OQ / PQ executionReview validation deliverables, test evidence, deviations, and remediation actionsPrepare systems for compliant go live and handover to operational support teamsSystems LandscapeExperience with several of the following systems is highly desirable:SingleLIMSChemiDoc-IT2 ImagerNuGenesis SDMSSDCViCell Blu32 KaratSecurity Administration / VISIONsecurityZS Xplorer Software / OmniTrust / OmniTrailQX Manager GxPLMS XchangeSoftMax Pro GxP (including Admin) to gSMPDiomniQuantStudio Test Development SoftwareWinKQCLImage Lab (ChemiDoc Gel Reader)gLabXEmpower 3 Enterprise GMP to gEmpowerRaw 2.0RequirementsRequired ProfileStrong experience in QC laboratory systems integration within GMP regulated environmentsProven track record in implementation of laboratory instruments and associated software platformsSolid understanding of computer system validation, data integrity, and GxP complianceExperience supporting IQ / OQ / PQ activities in collaboration with QAStrong stakeholder management across laboratory, IT, quality, and vendor organizationsAbility to manage multiple parallel workstreams in a complex program environmentExcellent communication and coordination skills in cross functional teamsPreferred BackgroundExperience in pharmaceutical, biotech, or life sciences environmentsStrong familiarity with QC laboratory workflows and analytical instrumentsKnowledge of regulated migration and system consolidation programsEngagement DetailsDuration: 18 monthsLocation: Preferred onsite in PhiladelphiaWorking Model: Hybrid / travel model possible, for example onsite every second week