Technical and Regulatory Knowledge: Strong working knowledge of GxP computerized systems compliance, including 21 CFR Part 11, EU GMP Annex 11 and Annex 15, ISPE GAMP guidance, computerized system validation, Computer Software Assurance, data integrity principles, SDLC, cloud-hosted GxP applications, IT infrastructure qualification, audit trail review, access controls, change control, cybersecurity controls impacting regulated systems, and risk management principles. Systems within scope may include, but are not limited to, LIMS, eQMS, MES, ERP, EBR, CTMS, EDC, pharmacovigilance systems, document management systems, infrastructure platforms, integration platforms, automated workflow technologies, data repositories, analytics platforms, data integrity tools, and cloud-hosted applications supporting GxP processes.