Director, R&D Validation Strategy

 Veeva Systems
 España
 Hace 2 días, 22 horas

We're looking for a candidate to this position in an exciting company.

  • Own. Refine and standardize the Vault Validation Methodology related to the customer’s portion of Vault validation.Assess current materials and collateral; refine and supplement as needed. Be accountable for ensuring a consistent message. Train internal resources on that message.
  • Be the thought leader. Work directly with global customers to guide on the complete Vault validation methodology (IQ/OQ/PQ), including educating on how best to leverage Veeva’s validation documentation. Conduct customer-facing meetings and workshops to advise on Vault validation best practices, GxP compliance, and the SaaS/Cloud/Agile validation methodology. Assess customers’ maturity, readiness and capabilities for Vault validation.
  • Ensure compliance.  Provide authoritative guidance to customers on Post-Go Live Validation/Change Control methodology and the Veeva Release Management process.
  • Represent. Establish clear communication channels with the internal Veeva Global Quality and Compliance Team and the the global field teams. Serve as the Veeva contact for all validation partner-related services.
  • Scale. Create a scalable model to support the growth across the North America, Europe and APAC regions.

  • Minimum of 10 years of compliance and/or validation experience within the Life Sciences industry and regulated environments (GMP, GCP, GLP, GVP)
  • Experience validating cloud-based systems
  • Knowledge of regulatory validation requirements, including CSV, 21 CFR Part 11 compliance, EU Annex 11, and the GAMP-V model
  • Proven experience influencing stakeholders
  • Ability to travel up to 25%
  • Western Europe or East Coast US based; authorized to work in one of these regions

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