QC Systems Integration Consultant (GMP Laboratory Systems)

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 kick off 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 / 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

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 / 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