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Director - Computer Systems Validation

Veeva Systems · Massachusetts - Boston · Remote

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About Veeva Systems

Veeva delivers the industry cloud for life sciences with applications, agents, data, and consulting. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,500 customers, ranging from the world's largest pharmaceutical...

About the role

The Director of Computer Systems Validation Program provides support to the Quality, Regulatory and Compliance function in support of qualification of Veeva Vault technology. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • Knowledge of Software Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering/sciences, a related discipline, or its equivalent and applicable industry experience
  • 10+ years of directly relevant experience in validation of enterprise software, computer information systems used in life sciences regulated environment (GMP, GCP, GLP, GvP)
  • Hands-on experience or working knowledge of risk-based validation, compliance frameworks, and governance for AI/ML-enabled capabilities in life sciences software
  • Previous managerial experience (5+) which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources
  • Demonstrated understanding of ERES regulations (e.g., 21 CFR Part 11, etc.)
  • Applied experience (i.e., through validation activities, audit support, and/or software system/software product compliance evaluation) in GCPs (e.g., ICH E6, 21 CFR 56, etc.), GMPs (e.g., 21 CRF 211, 21 CFR 820, etc.)
More 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 Director of Computer Systems Validation Program provides support to the Quality, Regulatory and Compliance function in support of qualification of Veeva Vault technology.

Primarily responsible for oversight of the assigned Validation teams to ensure on-time, on-budget delivery of computer system validation activities...

Read the full posting on Veeva Systems's site ↗

Quality & Security & Compliance - NA

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