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Veeva

Posted 2 days ago

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Audit Program Manager

LondonRemoteFull-time

AI Summary

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.

About this role

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.
At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.
As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.
Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

The Audit Program Manager role supports all aspects of Veeva’s audit and inspection management program, including the compliance outreach program. The Audit Program Manager is responsible for all areas of audit management including customer audits, management of corporate policies/procedures in the audit domain, internal audit/review of quality processes, regulatory intelligence for audit-related purposes, ISO9001 compliance, third-party independent industry audit program, managing customer-facing content, and audit/review of IT controls (e.g., SOC).

What You'll Do

  • Hosts customer audits and supports regulatory audits
  • Documents audit findings and authors audit response in relation to customer audit observations
  • Conducts internal audits in support of the annual audit plan
  • Manages informational requests for internal and external stakeholders
  • Performs compliance outreach presentations
  • Supports and coordinates with internal departments related to third-party audits (e.g. SOC, ISO)
  • Document review
  • Compliance support for the business
  • QMS system administration

    • Requirements

  • BS/BA in Science, Engineering, Information Management, related disciplines or equivalent work experience
  • 3+ years experience in a regulated quality / compliance role
  • Good understanding of regulations in the life sciences sector, either GxP (GMP, GCP, etc.) and/or ICH & ISO frameworks
  • Experience hosting audits and/or regulatory inspections or participating in as a subject matter expert
  • Excellent customer service skills with a strong focus on collaboration
  • Good knowledge of Microsoft applications (e.g., MS Excel, MS PowerPoint)
  • Strong verbal and written communication skills (English) principles of, and experience of engaging culturally diverse groups

    • Nice to Have

  • Solid foundation in Quality Principles and Standards used in the design, development, testing, and maintenance of software in a regulated environment (e.g., ISO, IEC, IEEE, ITIL, ICH)
  • 2+ years in an audit specific role in life sciences
  • Veeva products experience
  • Understanding of computer system validation
  • Understanding of best practices in information security and risk management

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