Validation Csv Expert Gdit R&d And Medical

IPSEN

Paris, France
Computer system validation (csv)
Gxp, fda, annex 11
Validation lifecycle management
Ipsen is strengthening its R&D and Medical Digital & IT organization to ensure the highest standards of compliance, quality, and audit readiness across its digital ecosystem

Job Summary

  • Ipsen is strengthening its R&D and Medical Digital & IT organization to ensure the highest standards of compliance, quality, and audit readiness across its digital ecosystem.
  • In this role, you will ensure that all computerized systems are fully compliant with regulatory requirements and internal quality standards, while enabling innovation and efficient delivery of digital solutions.
  • We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact.

Matching Summary

Ipsen is strengthening its R&D and Medical Digital & IT organization to ensure the highest standards of compliance, quality, and audit readiness across its digital ecosystem.

Skills & Requirements

Must-have

  • Computer System Validation (CSV)
  • GxP, FDA, Annex 11
  • Validation lifecycle management
  • Audit and inspection readiness
  • R&D IT systems experience
  • English fluency

Nice-to-have

  • Human-centric leadership
  • Collaborative and international environment
  • Strategic vision with hands-on execution
  • Transversal leadership skills

Key Requirements

  • 6-8 years of experience in CSV
  • Strong knowledge of regulatory frameworks
  • Solid experience managing validation lifecycle
  • Experience working with R&D systems
  • Ability to communicate with regulatory authorities

Work Rights

Not specified

Tailored Resume

Cover Letter