Principal Engineer, Digital Regulatory Assurance (Life Sciences)

This role serves as a senior subject matter expert in Software Lifecycle (SLC) processes, Computer Software Assurance (CSA), infrastructure qualification, regulatory compliance…

The incumbent is responsible for modernization of quality processes through automation, data-driven monitoring, dashboards, and AI-enabled solutions that improve compliance effectiveness…

This position bridges implementing regulatory requirements, technology solutions, and improvements to processes by enabling AI, automation, and data metrics.

Provide quality and regulatory oversight for GxP-relevant applications, infrastructure platforms, and technology solutions throughout the Software Lifecycle (SLC), ensuring compliance with regulatory requirements…

Strong experience in process optimization, AI enabled solutioning, audit-readiness, CAPAs and using/supporting DevOps tools and pipeline technologies.

Experience supporting regulatory audits/inspections and implementing quality monitoring solutions.

Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary validation practices.

Expert knowledge of GxP regulations required.