Senior Manager, GxP Systems & Validation

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 and industry standards.

Responsibilities:
- 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; improve validation methodologies using risk-based approaches
- Provide compliance guidance to executive leadership and functional heads
- Oversee administration and compliant operation of GxP systems (e.g., Laboratory systems, LIMS, MES, EDMS, enterprise SaaS)
- Ensure systems remain validated, secure, and audit-ready through changes, upgrades, and decommissioning
- Approve configurations/changes and access governance; ensure ALCOA+ data integrity controls
- Monitor system performance, audit trails, cybersecurity controls, and vendor compliance
- Lead enterprise validation initiatives; oversee URS, risk assessments, IQ/OQ/PQ, traceability, and summary reports
- Oversee regression testing, revalidation, documentation for inspection readiness, and act as SME during audits
- Oversee remediation for findings/deviations/CAPAs
- Lead cross-functional teams and third-party vendors; manage budgets/timelines/risks/resources; drive issue resolution
- Lead/mentor validation and system administration staff and build scalable capabilities

Requirements:
- Bachelor’s degree (Life Sciences/Engineering/IT or related); advanced degree preferred
- 8+ years GxP computerized systems and validation
- 3+ years leadership or program management experience
- Deep expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, and global data integrity requirements
- Experience leading complex enterprise system implementations
- Strong change control, deviation management, CAPA, and quality systems knowledge
- Ability to influence senior stakeholders and drive cross-functional alignment

Preferred:
- PMP (or equivalent); GAMP/ITIL (or related) compliance certification
- CSA transformation experience; GxP lab systems (LIMS, CDS, spectrophotometry; e.g., Openlab, Cary UV, Watson)
- Pharmaceutical/CRO experience; prior regulatory inspection leadership; risk-based decision-making; continuous improvement mindset

Wisconsin pay range: $145,000–$165,000. All applicants must have authorization to work in the US.