Freelancer profile translated to English.

Description

🚀 Currently on assignment within the IT & Cybersecurity Department of a French biotech company (CSV, NIST CSF, SOX, SOC 2 Type 2).

👤 7 years as France Manager for VSI/CSV activities for a logistics service provider storing and distributing pharmaceutical products (vaccines, anticancer drugs, plasma-derived medicinal products, etc.) as well as medical devices (glucose monitoring sensors) for renowned laboratories.

👤 11 years as AMOA Quality and IS Methods Engineer at L'Oréal Operations IT Department.

🔧 Areas of intervention: End-to-end validation of your GxP/GdP/GcP systems, risk analysis, IT supplier audits, change management, SOP writing, team training, assessment of VSI and Cybersecurity maturity level.

💻 Systems expertise: SAP S4HANA (numerous migrations and implementations), Electronic Signature (DOCUSIGN), QMS (MASTER CONTROL), Biostatistics software (SAS) and many others.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Marne La Vallée (up to 40km), Paris (up to 20km), Reims (up to 40km)

Confidentiel
VSI Consultant + Cybersecurity Compliance for a biotech in clinical phase
BIOTECH
October 2025 - Today (8 months)
Paris, France
- Support for a biotech company in its cybersecurity maturity development
- Software validation (Active Directory and SAS biostatistics)
CSV Validation NIST CSF NIS 2 GxP
PHARMARKETING
VSI Consultant for a biotech in clinical phase
PHARMACEUTICALS INDUSTRY
March 2025 - July 2025 (4 months)
🔹 Validation of the electronic signature tool (DocuSign CFR PART 11)
🔹 Coaching, IT supplier Audit, SOP Review
CSV Validation electronic signature 21 CFR Part 11
ARVATO
FRANCE VSI MANAGER
PHARMACEUTICALS INDUSTRY
March 2018 - March 2025 (7 years)
🔹 France VSI Manager for a pharmaceutical depot ensuring the logistics management of health products for major pharmaceutical laboratories (Roche, BMS, Vertex, ...) and medical device manufacturers (Abbott).

🔹 Deputy to the International VSI manager: boosting the network of international VSI representatives for the dissemination of best practices.

🔹 Management of a VSI officer

🔹 VSI contact for ANSM inspections, ISO 9001/13485 audits, ISMS audits, audits of compliance with Good Distribution Practices, and audits of over 15 pharmaceutical or medical device clients.

🔹 Systems Scope: SAP S/4 HANA, migration from AS400 to SAP R/3, SAP CRM, DOCUSIGN, MASTER CONTROL, as well as temperature monitoring software, labeling, site access control, among others.
VSI SAP S/4 HANA GAMP5 Annex 11 Project Management