Arrowhead Pharmaceuticals
Senior Manager, GxP Systems & Validation
Verona, Wisconsin, United States · Senior
Sponsorship not specified$145k-$165kDetected 18 days ago
CybersecurityProject ManagementVendor ManagementManual TestingFDA RegulatoryResearchAnimal StudiesLeadershipGxP
About the role
- The Senior Manager GxP Systems & Validation provides strategic and operational leadership for GxP-regulated computerized systems across their full lifecycle.
- The role combines system ownership and administration, validation project management, and organizational oversight to ensure enterprise-wide data integrity and computerized system compliance.
Responsibilities
- Maintain governance frameworks for GxP computerized systems
- Support modernization initiatives (e.g., SaaS adoption, cloud validation, CSA transition)
- Maintain validation and system lifecycle policies and standards
- Lead enterprise validation initiatives across multiple concurrent projects
- Manage validation master planning and resource allocation
- Ensure validation documentation supports global inspection readiness
- Maintain awareness of evolving global regulatory expectations
- Lead cross-functional teams across CMC, Quality, IS&I, Manufacturing, Engineering, GLP Operations, and external partners
- Manage budgets, timelines, risks, and resource planning for validation programs
- Drive issue resolution and escalation management
Requirements
- 8+ years of experience in GxP computerized systems and validation
- 3+ years in a leadership or program management role
- Deep expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, and global data integrity requirements
- Demonstrated experience leading complex, enterprise-level system implementations
- Strong understanding of change control, deviation management, CAPA, and quality systems
- Experience leading CSA transformation initiatives
- Candidates must have current, valid authorization to work in the country where this role is located.
Nice to have
- Bachelor's degree in Life Sciences, Engineering, IT, or related discipline (advanced degree preferred)
Skills
- Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
- Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
Compensation
- Wisconsin pay range
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This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.