Validation Csv Expert Gdit R&d And Medical

IPSEN

6-8 years computer system validation experience
Gxp fda 21 cfr part 11 annex 11 gamp5 knowledge
Full validation lifecycle management urs iq oq pq
Ipsen is seeking a CSV Manager to act as the quality gatekeeper for IT systems supporting R&D activities

Job Summary

  • Ipsen is seeking a CSV Manager to act as the quality gatekeeper for IT systems supporting R&D activities.
  • The role requires ensuring all computerized systems are fully compliant with global regulations like GxP and FDA while enabling innovation.
  • Candidates must lead audit readiness, manage change control processes, and collaborate closely with IT, Quality, and Regulatory stakeholders.

Matching Summary

Ipsen is seeking a CSV Manager to act as the quality gatekeeper for IT systems supporting R&D activities.

Skills & Requirements

Must-have

  • 6-8 years Computer System Validation experience
  • GxP FDA 21 CFR Part 11 Annex 11 GAMP5 knowledge
  • Full validation lifecycle management URS IQ OQ PQ
  • R&D system experience Veeva LIMS ELN
  • Audit and inspection readiness leadership

Nice-to-have

  • Strategic vision combined with hands-on execution
  • Strong stakeholder management in cross-functional teams
  • Fluent English communication skills
  • Ability to influence regulatory authorities
  • Collaborative international work environment

Key Requirements

  • 6-8 years experience in CSV within pharmaceutical or life sciences
  • Solid experience managing validation lifecycle and audit processes
  • Fluent in English language

Work Rights

Not specified

Tailored Resume

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