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, including 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 (SaaS, cloud validation, CSA transition)
- Serve as system owner/system administrator for critical GxP platforms; maintain validation and lifecycle policies
- Oversee compliant operation of GxP systems (Laboratory systems, LIMS, MES, EDMS, enterprise SaaS)
- Ensure systems remain validated, secure, and audit-ready; approve configurations/changes/access governance
- Ensure data integrity controls (ALCOA+); monitor performance, audit trails, cybersecurity, and vendor compliance
- Lead enterprise validation initiatives; oversee URS, risk assessments, IQ/OQ/PQ, traceability, summary reports
- Manage validation master planning/resource allocation; oversee regression testing and revalidation; act as SME in audits/inspections
- Oversee remediation for audit findings/deviations/CAPAs; support compliance guidance
- Lead cross-functional teams; oversee third-party vendors/consultants; manage budgets/timelines/risks
- Lead/mentor validation and system administration staff

Requirements:
- Bachelor’s degree (advanced degree preferred)
- 8+ years GxP computerized systems & validation; 3+ years in leadership/program management
- Deep expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, global data integrity
- Experience with enterprise system implementations, change control, deviations, CAPA/quality systems
- Ability to influence senior stakeholders and drive cross-functional alignment

Preferred:
- PMP (or equivalent); GAMP/ITIL or related compliance certification
- CSA transformation experience
- LIMS/Chromatography Data Systems/Spectrophotometry systems experience in a GxP environment
- Pharmaceutical/CRO experience; prior regulatory inspection leadership
- Risk-based decision-making; continuous improvement mindset

Application instructions:
- Authorization to work in the US for a company required.