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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