Principal Engineer, Digital Regulatory Assurance (Life Sciences)

Regulatory Jobs; North Chicago (IL); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical Insurance

401(k) Plan

Paid Time Off

Job summary

AbbVie is seeking a Principal Quality Engineer – Digital Regulatory Assurance to oversee regulatory quality for IT applications, infrastructure, and technology in a regulated life sciences environment. You will lead SLC/CSA activities, validation, and risk management, driving AI-enabled improvements and inspection readiness.

The role requires extensive experience with GxP, audits, and quality metrics, plus the ability to coach teams and advance a digital quality transformation across lifecycle

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related discipline; 7+ years experience, or Master’s with 6+ years, or PhD with 2+ years.
• Experience with CSA, digital transformation in quality, and validation practices.
• Strong knowledge of GxP regulations and regulatory audits/inspections.
• Proven ability to optimize processes, implement AI-enabled solutions, and drive quality improvements.

Responsibilities

• Provide regulatory quality oversight for GxP applications, infrastructure, and technology throughout the Software Lifecycle (SLC).
• Lead compliance monitoring, audits, health assessments, and quality metrics reporting.
• Partner with business and tech teams to embed validation and regulatory requirements into lifecycle activities.
• Drive CAPA, audit actions, and remediation planning with root cause analysis.

Skills

Process optimization

AI enablement

Audit readiness

DevOps tools & pipelines

Regulatory audits/inspections

Quality risk management

Project management

Documentation & coaching

Education

Bachelor's Degree in Engineering/CS/Life Sciences

Master’s Degree

PhD

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information, visit www.abbvie.com.

Role Overview

The Principal Quality Engineer – Digital Regulatory Assurance is responsible for providing regulatory assurance and quality oversight for IT applications, infrastructure platforms, and technology solutions operating within a regulated life sciences environment. This role serves as a senior subject matter expert in Software Lifecycle (SLC) processes, Computer Software Assurance (CSA), infrastructure qualification, regulatory compliance, and quality risk management.

The incumbent is responsible for modernization of quality processes through automation, data-driven monitoring, dashboards, and AI-enabled solutions that improve compliance effectiveness, streamline SLC activities, and strengthen inspection readiness. This position bridges implementing regulatory requirements, technology solutions, and improvements to processes by enabling AI, automation, and data metrics.

Responsibilities

• Provide quality and regulatory oversight for GxP-relevant applications, infrastructure platforms, and technology solutions throughout the Software Lifecycle (SLC), ensuring compliance with regulatory requirements, company standards, and quality expectations.
• Act as a trusted advisor on SLC, Computer Software Assurance (CSA), validation, infrastructure qualification, risk management, and regulatory compliance within a regulated life sciences environment.
• Lead compliance monitoring activities across assigned portfolios, including periodic reviews, audit trail reviews, validation health assessments, quality metrics, and overall lifecycle health reporting.
• Partner with business and technology teams to ensure quality, compliance, and validation requirements are built into the design, implementation, deployment, and ongoing support of technology solutions.
• Provide guidance on validation strategies, risk assessments, regulatory characterizations, deviations, CAPAs, audit observations, and other quality-related decisions.
• Lead audit and inspection readiness efforts, including preparation activities, evidence reviews, stakeholder coaching, audit support, and remediation planning.
• Drive CAPA and audit action management activities by promoting effective root cause analysis, sustainable corrective actions, timely implementation, and verification of effectiveness.
• Stay current on evolving regulatory requirements, industry trends, and emerging quality practices, and translate them into practical improvements for lifecycle processes and compliance programs.
• Serve as the primary SQA point of contact for digital process improvement initiatives, helping identify opportunities for standardization, automation, simplification, and AI enablement.
• Manage a pipeline of automation and AI opportunities, working with stakeholders and technical teams to prioritize, implement, and drive adoption of solutions that improve quality and compliance outcomes.
• Develop and maintain quality dashboards, compliance scorecards, key risk indicators, and executive reporting to provide visibility into compliance health, operational performance, and emerging risks.
• Facilitate governance reviews and cross-functional discussions to drive accountability, resolve compliance concerns, and support consistent application of quality and regulatory expectations.
• Coach and mentor practitioners and project teams on lifecycle execution, CSA principles, validation expectations, inspection readiness, and quality risk management.
• Represent SQA in governance forums, audits, inspections, and strategic initiatives, communicating risks, trends, and recommendations to business stakeholders and leadership.
• Lead continuous improvement efforts that strengthen quality processes, enhance compliance monitoring, and support AbbVie's digital quality transformation.

Required Qualifications

• Bachelor's Degree in Engineering, Computer Science, Life Sciences, or related discipline with 7 years' experience; OR Master’s Degree with 6 years' experience; OR PhD with 2 years' experience.
• 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.
• Project management, analytical, and documentation skills; ability to create knowledge materials and coach diverse audiences.
• Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary validation practices.
• Expert knowledge of GxP regulations required.

Preferred Qualifications

• Master’s Degree with minimum 6 years' supervisory experience preferred.
• Knowledge of other regulatory domain areas like SOX, Privacy, Security, AI/ML preferred.
• Professional certifications (e.g., ASQ CQA, PMP, Six Sigma) preferred.

Compensation & Benefits

• The compensation range is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation will depend on many factors including geographic location.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation: https://www.abbvie.com/join-us/reasonable-accommodations.html