Computerized System Validation Manager

Sanofi

Le Trait, France
Base: €42,400.00 - €56,533; bonus/equity: not spec...
Onsite
Computerized system validation experience in pharmaceutical industry
Gmp, gamp, and 21 cfr part 11 regulatory compliance
Ot system lifecycle management and risk assessment
The role involves developing and implementing the CSV strategy for Operational Technology (OT) systems within a global biopharmaceutical company

Job Summary

  • The role involves developing and implementing the CSV strategy for Operational Technology (OT) systems within a global biopharmaceutical company.
  • Candidates must ensure strict adherence to GMP, GAMP, and 21 CFR Part 11 regulations while managing the full lifecycle of OT systems.
  • Sanofi offers an environment focused on innovation, AI integration, and large-scale digital transformation to improve patient outcomes worldwide.

Matching Summary

The role involves developing and implementing the CSV strategy for Operational Technology (OT) systems within a global biopharmaceutical company.

Salary

Base: €42,400.00 - €56,533; Bonus/Equity: Not specified; Benefits: Company employee benefit programs eligible

Skills & Requirements

Must-have

  • Computerized System Validation experience in pharmaceutical industry
  • GMP, GAMP, and 21 CFR Part 11 regulatory compliance
  • OT system lifecycle management and risk assessment
  • Data integrity measures implementation for OT systems
  • Experience with Industry 4.0 technologies

Nice-to-have

  • Leadership and results-oriented mindset
  • Global network participation and knowledge sharing
  • Continuous process improvement promotion
  • Strong communication skills in English
  • Ability to drive digital transformation initiatives

Key Requirements

  • Scientific or IT degree (Bac +5 minimum)
  • Proven experience in pharmaceutical system validation
  • Fluency in English (reading, writing, speaking)

Work Rights

Not specified

Tailored Resume

Cover Letter