09/28/2026 updated
100 % available
Freelance IT Consultant | IS project coordination & management in regulated environments (GxP)
Montréjeau, France
Only remote
Master's – Project Manager in Computer Systems Design – AQUITCOM (2008)Data IntegrityProject ManagementSAP ERPTrackwiseGXPServicenowVMware
Independent IT consultant with 20 years in IT, including 10+ years managing projects in regulated pharmaceutical environments (GxP), at Merck and Boehringer Ingelheim.
What I do: lead the deployment of computerized systems, from scoping to go-live, and coordinate Group IT, Quality, Production, Validation, integrators and vendors.
- IT projects for new production lines (EUR 100K to 25M)
- Governance and lifecycle of computerized systems: Data Integrity, regulatory archiving, obsolescence
- GxP compliance (FDA, EMA, ANSM) and 21 CFR Part 11, coordination of qualification (IQ/OQ/PQ) with Quality and Validation
- CAPEX/OPEX budget, supplier and contract management
- Interfaces with automation (PLC, OPC UA) and industrial data collection
- Tools: Veeva Vault QMS, TrackWise, ServiceNow, AVEVA / OSIsoft PI, SAP, VMware, Windows Server
Available for long-term freelance assignments, remote with occasional travel, in France and internationally (French and English).
Experience
Professional experience10+ years
Freelancer since2026
Languages
ArabicGoodEnglishFluentFrenchNative speakerItalianGoodSpanishBasic knowledge
Project history
Freelance activity in IT project management and computerized systems governance.
Development of a quality management application: audit trail, electronic signatures, deviation and CAPA management (21 CFR Part 11, EU Annex 11).
Management of IT projects for production line implementation (EUR 100K to 25M) in compliance with 21 CFR Part 11 Data Integrity.
IT lead for the Toulouse site.
First IT point of contact for Production, Quality and Validation.
Steering of IT workstreams in the deployment of new production lines (investments of EUR 100K to 25M).
Coordination of Group IT teams and local support.
Interface with Automation teams (PLC, OPC UA, PDMS), industrial data collection and centralization systems within line projects and Data Integrity.
Operational maintenance of Production, Laboratory and Quality systems.
Documentation management: URS, specifications, risk assessments, IQ/OQ/PQ.
Data lifecycle management and regulatory archiving.
Supplier and vendor coordination.
Implementation of solutions compliant with 21 CFR Part 11 Data Integrity (FDA) across all production services of the site (upstream / downstream process / quality control / development).
Steering of the site's industrial IT projects (production, quality, development) in a regulated environment (GxP, 21 CFR Part 11).
Management of IT supplier commitments: needs analysis, RFQ and quote validation, CAPEX/OPEX trade-offs, maintenance contract follow-up and coordination with accounting departments.
Schedule management and coordination of local IT teams and providers.
Project KPI tracking and reporting to Production and Quality management.
Review of URS and vendor solutions, with subcontractor management.
Hardening of workstations and servers in a quality environment (GxP/GMP, IQ, OQ, PQ, client-server architectures, Citrix, MSSQL, VMware, NetApp, Commvault).
Archiving of regulatory data (15 to 30 years) with lifecycle tracking.
Data security and backup solutions.