Job Description
**No 3rd parties**
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**Candidates must be eligible to work in the US without restrictions**
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*Must be willing to work fully onsite in the San Franciscco Bay Area (without relocating)**
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Job Duties:
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- Cross-functional collaboration with IT, Clinical Operations, and Supply Chain to translate complex business needs into validated system enhancements.
- Oversee validation lifecycles, approving UAT/PQ strategies, and authoring critical CSV/DI compliance documentation including URS, FS, and risk assessments.
- Establish governance for cloud-based system solutions, user access design, and global system administration for enterprise SaaS tools such as Veeva QMS and Quality Docs.
- Lead internal and external regulatory inspection preparation, acting as the primary SME for computer validation health.
- Direct the tracking, escalation, and resolution of systemic quality deviations, changes, CAPAs, and continuous QMS improvements.
- Generate quality metrics and compliance reports to proactively track follow-up actions and optimize system performance.
- Maintain end-user support ecosystems by continuously updating business guidance policies, SOPs, and user reference documentation.
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Qualifications:
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- Bachelor’s degree in science, engineering, or IT
- Minimum of 5 years of direct hands-on experience implementing and maintaining the validated state of GxP computerized systems.
- Experience leading risk-based validation models, data integrity frameworks, databases, and computer networking principles.
- Proven technical knowledge of enterprise cloud platforms and platform administration (such as Veeva QMS and Quality Docs).
- Strong process improvement, negotiation, and communication skills to effectively drive cross-functional projects and translate technical concepts into user-friendly language
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