Principal Engineer, Digital Regulatory Assurance (Life Sciences)

AbbVie; United States; On-site; USD 130,000 - 180,000; Full time

Job summary

AbbVie seeks a Principal Quality Engineer–Digital Regulatory Assurance to provide regulatory assurance and quality oversight for IT applications and infrastructure in a regulated life sciences environment. You will lead governance, audits, validation, CAPAs, and automation initiatives to improve compliance and inspection readiness.

You will mentor teams, drive AI-enabled quality improvements, and partner with business and technology to embed robust quality across the lifecycle.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline with 7 years' experience, or Master’s with 6 years' experience, or PhD with 2 years' experience.
• Strong experience in process optimization, AI-enabled solutioning, audit-readiness, CAPAs, and DevOps tools & 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 portfolios, including reviews, audit trail reviews, validation health assessments and quality metrics.
• Partner with business and technology teams to embed quality, compliance and validation into design, implementation, deployment and support.
• Provide guidance on validation strategies, risk assessments, deviations, CAPAs, and audit observations.
• Lead audit and inspection readiness activities, including preparation, evidence reviews, stakeholder coaching, and remediation planning.
• Drive CAPA and audit action management with root cause analysis and timely verification of effectiveness.
• Stay current on evolving regulatory requirements and translate into practical lifecycle improvements.
• Serve as the primary SQA contact for digital process improvement, standardization, automation, and AI enablement.
• Manage a pipeline of automation and AI opportunities, prioritizing and driving adoption of solutions.
• Develop and maintain quality dashboards, compliance scorecards, and executive reporting to show compliance health and risks.
• Facilitate governance reviews and cross-functional discussions to ensure accountability for quality expectations.

Skills

Process optimization

AI-enabled solutions

Audit readiness

CAPA management

DevOps tools

DevOps pipelines

Regulatory audits

Project management

CSA knowledge

GxP regulations

Digital transformation

Education

Bachelor's degree in Engineering/CS/Life Sciences

Master's degree

PhD

Tools

DevOps tools

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 about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook,Instagram,XandYouTube.

The Principal Quality Engineer–Digital Regulatory Assuranceisresponsible forproviding regulatory assurance and quality oversight for IT applications, infrastructure platforms, and technology solutionsoperatingwithin 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 incumbentis responsible formodernization 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 bridgesimplementingregulatory requirements, technologysolutions,and improvements toprocesses by enablingAI,automation,and data metrics.

Responsibilities:

• Provide quality and regulatory oversight forGxP-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,validationhealth assessments, quality metrics, and overall lifecycle health reporting.
• Partnerwith 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 andinspectionreadiness 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,timelyimplementation, 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, helpingidentifyopportunities 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 andmaintainquality 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,inspectionreadiness, 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:

• 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 experienceinprocessoptimization,AI enabledsolutioning,audit-readiness, CAPAsand 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 materialsand coachdiverse audiences.
• Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary validation practices.
• Expert knowledge ofGxPregulations required.

Preferred:

• Master'sDegree with minimum 6years' supervisoryexperience preferred.
• Knowledgeofotherregulatory domain areas likeSOX, Privacy, Security, AI/MLpreferred.
• Professional certifications (e.g., ASQ CQA, PMP, Six Sigma)preferred.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

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.