Senior Digital Regulatory Assurance Engineer (AI)

SmartRecruiters, Inc.; North Chicago (IL); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie seeks a Principal Engineer for Digital Regulatory Assurance to provide regulatory oversight for IT applications and infrastructure within a regulated life sciences environment. You will act as a senior SME for Software Lifecycle processes and CSA, ensuring compliance with regulatory requirements and company standards.

The role modernizes quality processes through automation, data-driven dashboards, and AI-enabled solutions, strengthening inspection readiness and quality metrics, while

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline with 7 years' experience; OR Master's with 6 years; OR PhD with 2 years.
• Strong experience in process optimization, AI-enabled solutioning, audit-readiness, CAPAs, and supporting DevOps tools and pipeline technologies.
• Experience supporting regulatory audits/inspections and implementing quality monitoring solutions.

Responsibilities

• Provide quality and regulatory oversight for GxP-relevant applications, infrastructure platforms, and technology solutions throughout the Software Lifecycle.
• Act as a trusted advisor on SLC, CSA, validation, infrastructure qualification, risk management, and regulatory compliance.
• Lead compliance monitoring activities across assigned portfolios, including periodic reviews and quality metrics.
• Partner with business and technology teams to ensure quality and validation requirements are built into design and deployment.
• Provide guidance on validation strategies, risk assessments, regulatory characterizations, and CAPAs.
• Lead audit and inspection readiness efforts, including preparation activities and remediation planning.
• Drive CAPA and audit action management with root-cause analysis and timely verification.
• Stay current on evolving regulatory requirements and translate them into practical improvements.
• Represent SQA in governance forums, audits, inspections, and strategic initiatives.
• Coach teams on lifecycle execution and quality risk management.

Skills

Process optimization

AI-enabled solutions

Audit readiness

DevOps tools

Regulatory compliance

Education

Bachelor’s degree in Engineering or Computer Science

Master’s degree

PhD

Tools

DevOps pipelines

Job description

AbbVie seeks a Principal Engineer for Digital Regulatory Assurance to provide regulatory oversight for IT applications and infrastructure within a regulated life sciences environment. You will act as a senior SME for Software Lifecycle processes and CSA, ensuring compliance with regulatory requirements and company standards.

The role modernizes quality processes through automation, data-driven dashboards, and AI-enabled solutions, strengthening inspection readiness and quality metrics, while