GxP Systems Administrator

• System Administration & Ops: Provide end-to-end support for GxP and business applications, including incident resolution, access management, and job monitoring.
• Validation Leadership (CSV): Lead and execute the full CSV lifecycle-authoring, reviewing, and executing protocols using ValGenesis to ensure continuous audit readiness.
• Quality & Compliance: Manage Quality Events (Change Control, Deviations, CAPA) within the QMS to align with regulatory requirements.
• Infrastructure & Cloud Lifecycle: Oversee server upgrades, decommissioning, backup/restore testing, disaster recovery (DR) validation, and AWS/Azure cloud resource optimization.
• Security & Vulnerability: Drive security management, ensuring timely patching and risk remediation across all systems.
• Agile Project Management: Lead Agile/Scrum activities (daily stand-ups, sprint tracking) utilizing JIRA/Azure DevOps to keep cross-functional deliverables on track.
• Data & Training: Support system migrations (on-prem to cloud), maintain performance dashboards, and conduct instructor-led GxP training for stakeholders., This is a high-impact role where you will directly influence our operational excellence and compliance posture. You will work with a collaborative, cross-functional team in a dynamic environment right in the heart of Foster City.

Are you a seasoned IT professional who thrives at the intersection of life sciences compliance and cutting-edge cloud infrastructure?

We are seeking a Senior Analyst to lead system administration, computer system validation (CSV), and operational support within our life sciences environment. In this role, you will be the backbone of our compliant, reliable, and efficient systems-blending hands-on technical infrastructure management with rigorous GxP quality standards., * Education: Bachelor's degree in Computer Science, IT, or a related discipline.

• Experience: 8+ years of relevant IT experience, with a heavy focus on life sciences or regulated environments.
• Compliance Expertise: Demonstrated experience in GxP system administration and Computer System Validation (CSV).
• Technical Grip: Hands-on expertise in server/infrastructure management, disaster recovery, and cloud platforms (AWS/Azure).
• Tools of the Trade: Proficiency with validation/quality systems (ValGenesis, Veeva QMS or equivalents) and project tools (Azure DevOps, JIRA, MS Visio).

Nice-to-Haves

• Exposure to SAP ecosystems.
• Experience with automation and process optimization (RPA).

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