QC Systems Integration Consultant (GMP Laboratory Systems)
avacone Switzerland, Philadelphia, MS, United States
About The Role
We 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 Responsibilities
Lead implementation kickoff activities for multiple QC laboratory systems within a GMP regulated environment
Coordinate and oversee end‑to‑end system integrations across laboratory instruments, software applications, and enterprise platforms
Manage project execution against agreed scope, timeline, budget, and quality objectives
Drive alignment between laboratory operations, IT, vendors, QA, and validation stakeholders
Monitor implementation progress, identify risks, and proactively resolve integration issues
Support data migration and system consolidation activities across legacy and target platforms
Ensure proper documentation and compliance with internal CSV, CSA, and GxP requirements
Support QA and validation teams during IQ, OQ, and PQ execution
Review validation deliverables, test evidence, deviations, and remediation actions
Prepare systems for compliant go‑live and handover to operational support teams
Systems Landscape
Experience with several of the following systems is highly desirable:
SingleLIMS
ChemiDoc-IT2 Imager
NuGenesis SDMS
SDC
ViCell Blu
32 Karat
Security Administration / VISIONsecurity
ZS Xplorer Software / OmniTrust / OmniTrail
QX Manager GxP
LMS Xchange
SoftMax Pro GxP (including Admin) to gSMP
Diomni
QuantStudio Test Development Software
WinKQCL
Image Lab (ChemiDoc Gel Reader)
gLabX
Empower 3 Enterprise GMP to gEmpower
Raw 2.0
Requirements
Required Profile
Strong experience in QC laboratory systems integration within GMP regulated environments
Proven track record in implementation of laboratory instruments and associated software platforms
Solid understanding of computer system validation, data integrity, and GxP compliance
Experience supporting IQ, OQ, and PQ activities in collaboration with QA
Strong stakeholder management across laboratory, IT, quality, and vendor organizations
Ability to manage multiple parallel workstreams in a complex program environment
Excellent communication and coordination skills in cross‑functional teams
Preferred Background
Experience in pharmaceutical, biotech, or life sciences environments
Strong familiarity with QC laboratory workflows and analytical instruments
Knowledge of regulated migration and system consolidation programs
Engagement Details
Duration: 18 months
Location: Preferred onsite in Philadelphia
Working Model: Hybrid / travel model possible (for example onsite every second week)
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We 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 Responsibilities
Lead implementation kickoff activities for multiple QC laboratory systems within a GMP regulated environment
Coordinate and oversee end‑to‑end system integrations across laboratory instruments, software applications, and enterprise platforms
Manage project execution against agreed scope, timeline, budget, and quality objectives
Drive alignment between laboratory operations, IT, vendors, QA, and validation stakeholders
Monitor implementation progress, identify risks, and proactively resolve integration issues
Support data migration and system consolidation activities across legacy and target platforms
Ensure proper documentation and compliance with internal CSV, CSA, and GxP requirements
Support QA and validation teams during IQ, OQ, and PQ execution
Review validation deliverables, test evidence, deviations, and remediation actions
Prepare systems for compliant go‑live and handover to operational support teams
Systems Landscape
Experience with several of the following systems is highly desirable:
SingleLIMS
ChemiDoc-IT2 Imager
NuGenesis SDMS
SDC
ViCell Blu
32 Karat
Security Administration / VISIONsecurity
ZS Xplorer Software / OmniTrust / OmniTrail
QX Manager GxP
LMS Xchange
SoftMax Pro GxP (including Admin) to gSMP
Diomni
QuantStudio Test Development Software
WinKQCL
Image Lab (ChemiDoc Gel Reader)
gLabX
Empower 3 Enterprise GMP to gEmpower
Raw 2.0
Requirements
Required Profile
Strong experience in QC laboratory systems integration within GMP regulated environments
Proven track record in implementation of laboratory instruments and associated software platforms
Solid understanding of computer system validation, data integrity, and GxP compliance
Experience supporting IQ, OQ, and PQ activities in collaboration with QA
Strong stakeholder management across laboratory, IT, quality, and vendor organizations
Ability to manage multiple parallel workstreams in a complex program environment
Excellent communication and coordination skills in cross‑functional teams
Preferred Background
Experience in pharmaceutical, biotech, or life sciences environments
Strong familiarity with QC laboratory workflows and analytical instruments
Knowledge of regulated migration and system consolidation programs
Engagement Details
Duration: 18 months
Location: Preferred onsite in Philadelphia
Working Model: Hybrid / travel model possible (for example onsite every second week)
#J-18808-Ljbffr