Principal Engineer, Digital Regulatory Assurance (Life Sciences)

Role: Principal Quality Engineer – Digital Regulatory Assurance, focusing on ensuring regulatory compliance and quality oversight for IT applications and infrastructure within a regulated life sciences setting. Responsibilities: lead GxP compliance monitoring, validation, risk management, and audit readiness for digital solutions; drive modernization through automation, data metrics, and AI; develop dashboards, compliance scorecards, and support cross-functional governance; mentor teams on lifecycle processes, CSA principles, and validation best practices; represent SQA in audits, inspections, and strategic initiatives; identify and prioritize opportunities for digital quality improvements. Requirements: Bachelor's in Engineering, Computer Science, or Life Sciences with 7+ years' experience, including process optimization, AI-enabled solutions, and supporting regulatory audits; deep knowledge of GxP, software validation, and digital transformation; project management and documentation skills. Preferred: Master’s degree with supervisory experience, certifications (e.g., ASQ CQA, PMP, Six Sigma), knowledge of SOX, Privacy, AI/ML. High-Value: digital quality in life sciences, GxP compliance, validation, automation, AI-enabled monitoring, cross-functional collaboration. WorkSetup: not specified; likely hybrid or remote based on role scope.