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Senior Manager, GxP Systems & Validation
Arrowhead Pharmaceuticals
Verona, USA
Full-time
Senior · 8+ years experience
Onsite
USD 145000-165000 yearly / year
Discovered 1 weeks ago
LIMSLaboratory Information Management SystemsSaaSOpenlabCary UV systemsChromatography Data Systems
Free
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LIMSLaboratory Information Management SystemsSaaS
Key Skills for This Role
LIMSLaboratory Information Management SystemsSaaSOpenlabCary UV systemsChromatography Data Systems
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The Position
The Senior Manager GxP Systems & Validation provides strategic and operational leadership for GxP-regulated computerized systems across their full lifecycle. This role is accountable for governance, validation strategy, inspection readiness, and compliant system administration, ensuring alignment with global regulatory requirements (FDA, EMA, MHRA, ICH) and evolving industry standards (GAMP 5, CSA).
This leader serves as a key partner to Manufacturing, Quality, CMC, CSA and Compliance, GLP Operations, and external vendors, driving scalable compliance frameworks while enabling business agility. The role combines system ownership and administration, validation project management, and organizational oversight to ensure enterprise-wide data integrity and computerized system compliance.
Responsibilities
Strategic Leadership & Governance
Maintain governance frameworks for GxP computerized systems
Define validation strategies aligned with GAMP 5 and CSA principles
Support modernization initiatives (e.g., SaaS adoption, cloud validation, CSA transition)
Serve as system owner and system administrator for critical GxP platforms
Maintain validation and system lifecycle policies and standards
Participates in continuous improvement of validation methodologies, templates, and risk-based approaches
Provide compliance guidance to executive leadership and functional heads
System Lifecycle Oversight
Oversee administration and compliant operation of GxP systems (Laboratory systems, LIMS, MES, EDMS, enterprise SaaS platforms)
Ensure systems remain validated, secure, and audit-ready throughout implementation, upgrades, and decommissioning
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