Strategy | Steering and Governance for the activities related to the GxP Compliance of CS for the company group (international) • Construction and implementation of the service offer • Management of the service center and tutoring of an apprentice • Definition of the Business Plan, Roadmap and Projects prioritization to 2021-2025 • Participation in Inspections and Audits • Central Systems Validation Master Plan • Animation of the international community of computerized systems validation • IT infrastructure qualification strategy • Training & Onboarding for newcomers related to the GxP compliance of computerized systems
Success: Definition and structuring of the service offering, Confidence, Efficiency, Creation of an international community, Integration of IT quality reflexes Communication Skills
Operationnal | Computerized Systems Validation for centralized and deployed IS (Core Model and Roll-Out) • Construction of compliance dossier for several systems | Validation deliverables (Validation Plan and Report, Risk Analysis, Protocols, Deviations, Incidents, Test, Report, Migration - keywords: IQ/OQ/PQ). • Impact analysis and definition of the maintenance of compliant systems in operation • Support for the definition of processes and needs, writing of user guides, administrator, technical architecture file, data flow, functional risk assessment • Processing of GxP changes, incidents, problems and validation non-conformities (ITSM), deviations, CAPA etc.
Success: Record time to build the ITSM compliance file despite the health context
Cybersecurity • Construction, implementation and management of a cybersecurity awareness program for the company's 6000 employees • Reporting of the activity and management of the weekly points of the network and security team with the objective of structuring and making visible the different technical projects
Success: Involvement of international IT platforms, phishing simulation campaigns and e-learning strategy (contents, planification, "bad-clickers" "VAP", etc.)
IT Business Partner & Project Management • Support for the definition of user requirements for the digitization of the global archive management process, RFP contribution • Fluidification of relations - Interface with Business - IT - Purchasing - Legal departments • Contribution for implementing an IT project management methodology • Realization of the associated opportunity study and selection of the supplier • Contribution to the investment committee presentation
Success: Supplier selection process, integration of GxP constraints, acceptance by the investment committee.