Veeva Systems · 9 hours ago
Director - Computer Systems Validation
United States
Full-time
Remote
Director/Executive
$130K/yr - $230K/yr
10+ years expVeeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. The Director of Computer Systems Validation Program will provide support to the Quality, Regulatory and Compliance function, overseeing validation teams to ensure compliance with regulatory requirements and successful delivery of validation activities.
BiotechnologyCRMEnterprise SoftwareSoftware
Responsibilities
Manage/mentor a validation team of validation program managers / team leads (direct reports) on validation projects of Veeva and internal business systems to ensure deliverables conform to company and regulatory requirements
Responsible to deliver validation projects under strict deadlines to ensure customer success. Review and approve validation approach, method, and reporting (VPP, VIA, VSR) during periodic releases of Veeva software products
Establish validation processes commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality
Oversee on-shore and off-shore team of validation contractors testing of Veeva products to ensure deliverables conform to defined budgets and timelines
Act as executive management interface between Product Development, Operations, Security, and Quality Assurance/Compliance regarding Computer Systems validation exigencies and problem resolution
Support planning and execution of product and internal system periodic reviews
Execute other projects/duties as assigned to ensure compliance across Veeva’s product line and internal business systems
Qualification
Required
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
A minimum of 10+ years directly relevant experience in validation of enterprise software, computer information systems used in life sciences regulated environment (GMP, GCP, GLP, GvP)
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.)
Use and/or development of risk-based, critical thinking decision-making models to inform validation related activities
Excellent project management, communication, and technical writing skills are required
The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management
Proven ability working in a matrix environment and leading multi-level / cross functional teams to achieve the highest performance in meeting site and departmental objectives
Preferred
Exposure to Agile SDLC, SaaS, AI, and/or IT cloud technologies
Awareness of various global standard frameworks such as ISO, SEI, ITIL
Exposure to global Health Authorities (e.g., FDA, EMA, Health Canada, MHRA, etc.) with respect to computer system validation & data integrity
Experience with automated testing technologies
Benefits
Medical, dental, vision, and basic life insurance
Flexible PTO and company paid holidays
Retirement programs
1% charitable giving program
Company
Veeva Systems
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry.
5001-10000 employees
H1B Sponsorship
Veeva Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (60)
2023 (52)
2022 (73)
2021 (55)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$7MKey Investors
Emergence Capital
2013-10-16IPO
2008-06-05Series Unknown· $4M
2007-02-06Angel· $3M
Leadership Team
Peter Gassner
Founder and CEO
Mitch Wallace
Retired - Co-Founder and VP Operations
Recent News
2026-01-09
2026-01-06
2026-01-06
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