Sr. R&D IT Manager
Core
IT System Owner for GxP and business-critical applications in a late-stage biotech company, ensuring technical health, regulatory readiness, and lifecycle management for R&D and clinical operations.
Role type
Senior IT Manager (GxP Systems)
Builds
Validated laboratory systems (LIMS, chromatography data systems), scientific data platforms, and integrated business applications for clinical and R&D teams.
Domain
Biotechnology / Life Sciences / GxP Compliance
Required skills
GxP system lifecycle management, Computer System Validation (CSV), application architecture, vendor management, project leadership, data integrity controls, security administration, root-cause analysis, stakeholder communication
Preferred skills
Advanced degree, professional certifications, experience with low-code platforms, workflow automation, Microsoft Copilot, AI technologies
Technologies
LIMS, chromatography data systems, laboratory instrument software, scientific data platforms, Microsoft Copilot, low-code platforms
Responsibilities
Serve as IT System Owner for assigned GxP applications; partner with QA and CSV to determine validation strategies; lead complex system implementations and migrations; administer application configuration and security controls; maintain inspection-ready documentation; manage contractors and vendors; develop lifecycle roadmaps and recommend automation opportunities; mentor colleagues on IT System Owner practices.
Seniority
Senior, hands-on IC with leadership responsibilities