Computer System Validation Lead / Program Manager
$85,000–$120,000 year
Remote · San Francisco, California, United States
Job Summary
Lead and execute computer systems validation activities for Veeva’s cloud-based validation platform across general releases and hot fixes, ensuring timely delivery, risk-based testing, and regulatory compliance. Serve as CSV planner/advisor, develop and maintain validation deliverables (IQ/OQ, VPP, VSR, trace matrices), coordinate with Product Management and SQA, maintain traceability, and support change control. This is a work-anywhere, full-time role with a focus on validation of enterprise applications (e.g., SAP, eTMF, CTMS, LIMS, QMS) in regulated life-sciences contexts, aligning with 21CFR11/Annex 11, ISPE, and related standards, to accelerate customer adoption of Veeva’s cloud platform.
Required Qualifications
- Bachelor’s degree in Engineering/ Sciences or equivalent relevant technical experience
- At least 3+ years of experience in CSV role
- Hands-on experience with validation of enterprise applications (e.g., SAP) used in conduct of commercial regulated activities and/or supporting industry applications (e.g., eTFM, CTMS, LIMS, QMS, DCS)
- Strong understanding of relevant industry regulations (e.g., 21CFR11/Annex 11, 21CFR211, 21CFR820, etc.) and standards (ISO 9001, ASTM E2500, ISPE Baseline Guides)
- Familiarity with Agile software development, business analysis and/or software testing methodologies
- Excellent written and oral communication skills
- Nice to Have: experience with cloud-based applications, Agile development, CSA/RBV, AI in life sciences, GAMP 5
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