Senior Manager, GxP Systems & Validation

Role: Senior Manager GxP Systems & Validation, leading lifecycle governance and validation strategy for GxP-regulated computerized systems in biopharma. Responsibilities: establish compliance frameworks, oversee system administration, validation projects, and lifecycle management across platforms like LIMS, MES, EDMS; ensure audit readiness and data integrity; lead validation initiatives, manage vendors, and support modernization efforts including SaaS/cloud validation; mentor validation staff. Requirements: Bachelor’s in Life Sciences, Engineering, or IT; 8+ years in GxP systems validation; 3+ years leadership; expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, data integrity; proven experience in enterprise system implementation and regulatory inspections. Preferred: project management certifications (PMP), GAMP/ITIL, experience with laboratory systems (LIMS, chromatography data), and in pharma or CRO environments. HighValue: focus on GxP computerized systems, validation, data integrity, and compliance within biopharma manufacturing and quality contexts. WorkSetup: based in Wisconsin with strategic oversight responsibilities; no specific travel mentioned.