Senior Manager, GxP Systems & Validation

Responsibilities

• Maintain governance frameworks for GxP computerized systems
• Define validation strategies aligned with GAMP 5 and CSA principles
• Serve as system owner and system administrator for critical GxP platforms
• Oversee administration and compliant operation of GxP systems (Laboratory systems, LIMS, MES, EDMS, enterprise SaaS platforms)
• Lead enterprise validation initiatives across multiple concurrent projects
• Lead cross-functional teams across CMC, Quality, IS&I, Manufacturing, Engineering, GLP Operations, and external partners
• Lead, mentor, and develop validation and system administration staff

Requirements

• Bachelor’s degree in Life Sciences, Engineering, IT, or related discipline (advanced degree preferred)
• 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
• Proven ability to influence senior stakeholders and drive cross-functional alignment

Preferred

• PMP or equivalent project management certification
• GAMP, ITIL, or related compliance certification
• Experience leading CSA transformation initiatives
• Extensive experience related to administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson)
• Pharmaceutical or CRO experience
• Prior regulatory inspection leadership experience
• Risk-based decision making
• Continuous improvement mindset