Senior Manager, GxP Systems & Validation
Arrowhead Pharmaceuticals
August 07, 2026
Remote friendly (Verona, WI)
United States
$145,000 - $165,000 USD yearly
IT
The Senior Manager GxP Systems & Validation provides strategic and operational leadership for GxP-regulated computerized systems across their full lifecycle, ensuring governance, validation strategy, inspection readiness, and compliant system administration aligned with global regulatory requirements.
Responsibilities:
- Maintain governance frameworks for GxP computerized systems; define validation strategies aligned with GAMP 5 and CSA
- Support modernization initiatives (e.g., SaaS adoption, cloud validation, CSA transition)
- Serve as system owner and administrator for critical GxP platforms; maintain lifecycle policies/standards
- Oversee administration and compliant operation of GxP systems (LIMS, MES, EDMS, enterprise SaaS, etc.); ensure validated, secure, audit-ready systems
- Ensure ALCOA+ data integrity controls; monitor performance, audit trails, cybersecurity, and vendor compliance
- Lead enterprise validation initiatives; manage URS, risk assessments, IQ/OQ/PQ, traceability, summary reports
- Oversee regression testing, revalidation, regulatory inspection readiness, SME support, and remediation (deviations/CAPAs)
- Lead cross-functional teams and manage third-party vendors/consultants, budgets, timelines, risks, and escalations
- Lead/mentor validation and system administration staff
Requirements:
- Bachelor’s degree (Life Sciences/Engineering/IT or related; advanced preferred)
- 8+ years GxP computerized systems/validation; 3+ years leadership/program management
- Expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, global data integrity
- Experience leading enterprise implementations; change control, deviations, CAPA, quality systems; influence senior stakeholders
Preferred:
- PMP/equivalent; GAMP/ITIL or compliance certification; CSA transformation experience
- Experience with LIMS/Chromatography Data Systems/Spectrophotometry systems in GxP (Openlab, Cary UV systems, Watson)
- Pharmaceutical/CRO experience; regulatory inspection leadership; risk-based decision making; continuous improvement
Wisconsin pay range: $145,000–$165,000. All applicants must have authorization to work in the US.
Responsibilities:
- Maintain governance frameworks for GxP computerized systems; define validation strategies aligned with GAMP 5 and CSA
- Support modernization initiatives (e.g., SaaS adoption, cloud validation, CSA transition)
- Serve as system owner and administrator for critical GxP platforms; maintain lifecycle policies/standards
- Oversee administration and compliant operation of GxP systems (LIMS, MES, EDMS, enterprise SaaS, etc.); ensure validated, secure, audit-ready systems
- Ensure ALCOA+ data integrity controls; monitor performance, audit trails, cybersecurity, and vendor compliance
- Lead enterprise validation initiatives; manage URS, risk assessments, IQ/OQ/PQ, traceability, summary reports
- Oversee regression testing, revalidation, regulatory inspection readiness, SME support, and remediation (deviations/CAPAs)
- Lead cross-functional teams and manage third-party vendors/consultants, budgets, timelines, risks, and escalations
- Lead/mentor validation and system administration staff
Requirements:
- Bachelor’s degree (Life Sciences/Engineering/IT or related; advanced preferred)
- 8+ years GxP computerized systems/validation; 3+ years leadership/program management
- Expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, global data integrity
- Experience leading enterprise implementations; change control, deviations, CAPA, quality systems; influence senior stakeholders
Preferred:
- PMP/equivalent; GAMP/ITIL or compliance certification; CSA transformation experience
- Experience with LIMS/Chromatography Data Systems/Spectrophotometry systems in GxP (Openlab, Cary UV systems, Watson)
- Pharmaceutical/CRO experience; regulatory inspection leadership; risk-based decision making; continuous improvement
Wisconsin pay range: $145,000–$165,000. All applicants must have authorization to work in the US.