At Veeva, we build enterprise cloud technology that powers the biggest names in the pharmaceutical, biotech, consumer goods, chemical & cosmetics industries. Our customers make vaccines, life-saving medicines, and life-enhancing products that make a difference in everyday lives. Our technology has transformed these industries; enabling them to get critical products and services to market faster. Our core values, Do the Right Thing, Customer Success, Employee Success, and Speed, guide us as we make our customers more efficient and effective in everything they do.
Veeva Systems is looking for a global Director for R&D Validation Strategy to define, refine and align the Vault UAT/PQ validation methodology and strategy for our customers. Candidates for this position must have a minimum of 10 years of compliance and/or validation experience within the Life Sciences industry, and specific experience validating GxP cloud-based systems. In this role, the Director is expected to be a thought leader for and evangelize best practices, both internally and with our customers.
What You'll Do
- Own. Refine and standardize the Vault Validation Methodology related to the customers 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 Veevas 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
Nice to Have
- Direct experience with Veeva Vault
- Experience with Health Authority Inspections and internal/external audits
- Life Sciences, computer science, technology or related degree
Veevas headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.
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