Director, CSV & AI Validation

Veeva Systems; United States; Remote; USD 150,000 - 230,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Flexible PTO

Retirement programs

Charitable giving

Job summary

Veeva Systems, a leading life sciences SaaS provider, seeks a Director of Computer Systems Validation to lead CSV efforts for Vault technology. You will mentor validation teams, govern validation strategies, and ensure compliance with GxP and regulatory standards during releases and audits.

The role emphasizes risk-based validation, AI/ML governance, cross-functional collaboration, and executive-facing issue resolution across Product Development, Operations, Security, and Compliance.

Qualifications

• B.S. in engineering/sciences or related field with industry experience in validation.
• 10+ years of enterprise software validation in life sciences, GMP/GCP GLP environments.
• Experience with AI/ML governance and risk-based validation.
• Previous managerial experience demonstrating leadership and budgeting skills.
• Knowledge of 21 CFR Part 11 and related regulations (GxP).
• Strong writing, communication, and cross-functional collaboration skills.

Responsibilities

• Lead and mentor a validation program team to deliver on-time validation projects.
• Review and approve validation approaches, methods, and reporting during releases.
• Establish risk-based validation processes aligned with regulatory requirements.
• Oversee on-shore/off-shore validation contractors and ensure budgets/timelines.
• Interface with Product Development, Operations, Security, and QA/Compliance.
• Support product/system periodic reviews and audits as needed.
• Execute additional projects to ensure compliance across products.

Skills

Program management

GxP compliance

AI/ML governance

Regulatory compliance

Leadership / mentoring

Validation strategy

Quality Assurance

Cross-functional collaboration

Education

B.S. in engineering/sciences

Tools

Validation frameworks

Risk-based validation

Audit support tools

Job description

Veeva Systems, a leading life sciences SaaS provider, seeks a Director of Computer Systems Validation to lead CSV efforts for Vault technology. You will mentor validation teams, govern validation strategies, and ensure compliance with GxP and regulatory standards during releases and audits.

The role emphasizes risk-based validation, AI/ML governance, cross-functional collaboration, and executive-facing issue resolution across Product Development, Operations, Security, and Compliance.