Principal Engineer, Digital Regulatory Assurance (Life Sciences)
Core
Provide regulatory assurance and quality oversight for IT applications, infrastructure platforms, and technology solutions in a regulated life sciences environment, acting as a senior subject matter expert in Software Lifecycle (SLC) processes and Computer Software Assurance (CSA).
Role type
Principal Quality Engineer (Digital Regulatory Assurance)
Builds
Automated quality monitoring solutions, dashboards, and AI-enabled compliance tools (via careerplan.io/jobs/3743990015837635-principal-engineer-digital-regulatory-assurance-life-sciences-at-abbvie)
Domain
Life Sciences / Regulatory Compliance / Software Engineering
Deliverable
production ML models | dashboards & analysis
Required skills
GxP regulations, Computer Software Assurance (CSA), validation, risk management, process optimization, AI solutioning, DevOps tools, audit readiness, CAPA management, data metrics
Preferred skills
Supervisory experience, SOX/Privacy/Security knowledge, AI/ML domain expertise, professional certifications (ASQ CQA, PMP, Six Sigma)
Technologies
DevOps tools, AI/ML frameworks, automation platforms
Responsibilities
Provide quality and regulatory oversight for GxP-relevant applications throughout the Software Lifecycle; Lead compliance monitoring activities including periodic reviews, audit trail reviews, and validation health assessments; Partner with business and technology teams to embed quality and validation requirements into design and deployment; Lead audit and inspection readiness efforts including evidence reviews and stakeholder coaching; Drive CAPA and audit action management activities; Develop and maintain quality dashboards, compliance scorecards, and executive reporting; Coach and mentor practitioners on lifecycle execution and inspection readiness.
Seniority
Principal, hands-on IC with strategic mentorship