Principal Digital Regulatory Assurance Engineer

AbbVie Inc.; Chicago (IL); Hybrid; USD 140,000 - 190,000; Full time

Job summary

AbbVie seeks a Principal Digital Regulatory Assurance to ensure IT operations and software lifecycles meet regulatory standards. The role leads quality systems optimization through automation, AI-enabled solutions, and DevOps best practices, collaborating with BTS Quality and cross-functional teams.

The incumbent drives CI/CD improvements, incident management, and continuous quality assurance across the IT solution lifecycle, ensuring efficient deployments and audit readiness.

Qualifications

• Bachelor’s degree plus 7 years of experience.
• Master’s degree plus 6 years of experience is preferred.
• PhD plus 2 years of experience is acceptable.

Responsibilities

• Develop, implement, and champion solution/change strategies that align with regulatory requirements, using AI-enabled automation.
• Standardize DevOps practices by integrating tools across CI/CD pipelines, testing, deployment, and monitoring.
• Lead modernization of QA frameworks and adoption of automation, validation pipelines, and intelligent monitoring.
• Automate Software Lifecycle processes with tools for validation, documentation, and workflow management.
• Monitor technology lifecycle processes with automated dashboards and alerts for performance and compliance.
• Serve as primary contact for quality incidents, coordinate investigations and corrective actions.
• Stay current with regulatory standards and update SLC procedures accordingly.
• Represent SQA in strategic forums and regulatory engagements with clear communication of outcomes.

Skills

DevOps practices

Automation pipelines

CI/CD

Analytics

Project management

Cross-functional teamwork

Policy coaching

Education

Bachelor’s degree

Master’s degree

PhD

Tools

Jira

Confluence

qTest

Jenkins

GitLab

AWS

Azure DevOps

Job description

Company 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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

ThePrincipal Digital Regulatory Assurance is responsible forensuring that AbbVie's IT operations and software lifecycle processes fullycomply withregulatory requirements and corporate standards. This roleprovidesleadership in defining, implementing, andoptimizingquality systems through digital enablement and AI-driven solutions, and involves direct collaboration with cross-functional teams, Business stakeholders, and the Business Technology Services (BTS) Quality organization.This techno-functional expert transforms traditional quality assurance by implementing automation frameworks and DevOps best practices that enhance efficiency, reduce cycle times, and ensure regulatory compliance whileoptimizingCI/CD pipelines

ThePrincipal Digital Regulatory Assurancewill provide oversight of quality activities, especially across Technology Lifecycle processmonitoringand incident management, drive improvement initiatives, troubleshoot IT quality issues, and support all phases of the IT solution lifecycle. The incumbent acts as the primary point of contact between business units and quality teams, ensuring mutual understanding of needs andmaintainingeffective service agreements.

Key Responsibilities:

• Develop, implement, and champion solution/change strategies that align with organizationalobjectivesand evolving regulatory requirements,leveragingAI-powered solutions and automation to enhance compliance monitoring and operational efficiency.

• Leverage extensive DevOps process and toolchainexpertiseto standardize, streamline, and simplify DevOps practices by integrating andoptimizingtools across CI/CD pipelines, automated testing, deployment, and monitoring capabilities.

• Lead continuous improvement and digital enablement initiatives, focusing on modernizing quality assurance frameworks and driving adoption of advanced automation, validation pipelines, and intelligent process monitoring.

• Drive automation of Software Lifecycle (SLC) processes by developing and deploying automated validation tools, intelligent documentation generation, and workflow solutions to reduce manual effort and cycle times.

• Manage technology lifecycle process monitoring,establishautomated dashboards andalertsfor system performance, and implement targeted improvements to ensureoptimalcompliance and efficiency.

• Serve as the primary point of contact for incident management related to quality events and deviations, coordinate investigations, root cause analysis, and ensure effective corrective actions.

• Monitor and update SLC procedures in response to changes in regulatory standards and industry best practices.

• Represent SQA on strategic forums, steering committees, and regulatory engagements; communicate quality outcomes, audit results, and improvements to partners and stakeholders.

• Support and manage regulatory audits and inspections, oversee CAPA investigations and remediation activities, ensuringtimelyimplementation and closure.

• Provide expert mentorship on DevOps best practices, automation, computerized system quality, policy interpretation, and new quality technologies.

• Lead training initiatives for internal teams and business stakeholders on IT Quality standards, SLC procedures, and new tools/technologies.

• Oversee documentation and evidence management tomaintaincompliance andfacilitateinvestigations and audit readiness.

• Assist Center of Excellence (CoE) leadership with SLC communications, newsletters, and internal coordination efforts.

• Escalate and resolve significant quality exceptions, risks, and issues with minimal supervision.

• Engage in infrastructure change management and risk reviewactivities, submittimelyrisk assessments tomaintaincompliance and business continuity.

• Develop,monitor, and interpret SQA metrics and trends using automated analytics,identifyingqualitygapsand preparing actionable dashboards and reports for senior leadership.

Qualifications

Required:

• Bachelor’s degree plus 7 years of experience, master’s degree plus 6 years of experience, PhD plus 2 years of experience.

• Provenexpertisein DevOps toolchains (e.g., Jira, Confluence,qTest, Jenkins, GitLab, AWS and Azure DevOps), automation pipelines, and CI/CD.

• Experience managing SQA practices, validation strategy,riskand incident management/mitigation.

• Experience supporting regulatory audits and compliance (FDA or similar agencies).

• Strong skills in analytics, project management, process improvement, and cross-functional collaboration.

• Ability to coach teams in policy, SLC execution, and regulatory requirements.

• Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary validation practices.

• Professional certifications (e.g., ASQ CQA, PMP, Six Sigma)preferred.

Preferred:

• Provenexpertisein DevOps toolchains (e.g., Jira, Confluence,qTest, Jenkins, GitLab, AWS and Azure DevOps), automation pipelines, and CI/CD in life sciences industry.
• Supervisory experience.
• Professional certifications (e.g., ASQ CQA, PMP, Six Sigma).

Additional Information

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.

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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html