Principal Engineer, Digital Regulatory Assurance (Life Sciences)

BioSpace; North Chicago (IL); Vor Ort; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits package

Long-term incentive programs

401(k) retirement plan

Zusammenfassung

AbbVie is seeking a Principal Quality Engineer – Digital Regulatory Assurance to lead regulatory and quality oversight for IT applications, infrastructure platforms, and technology solutions in a regulated life sciences environment.

The role focuses on modernizing quality processes through automation, data-driven monitoring, dashboards, and AI-enabled solutions that enhance compliance, streamline SLC activities, and strengthen inspection readiness.

Qualifikationen

• Bachelor’s degree with 7+ years or advanced degree with 6+ years or PhD with 2+ years (from the required education).
• Experience in CSA, GxP regulatory requirements, and digital quality transformation.
• Experience supporting regulatory audits/inspections and implementing quality monitoring solutions.
• Strong project management, analytical, and documentation skills, plus ability to coach diverse audiences.
• Knowledge of CSA, digital transformation in quality, and contemporary validation practices.
• Expert knowledge of GxP regulations.

Aufgaben

• Provide regulatory and quality oversight for SLC-relevant applications, infrastructure, and tech solutions to ensure regulatory compliance.
• Act as SME on SLC, CSA, validation, infrastructure qualification, risk management, and compliance.
• Lead compliance monitoring across portfolios with reviews, validation health assessments, and quality metrics.
• Partner with business and tech teams to embed quality and validation requirements in design, 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, and remediation planning.
• Drive CAPA and audit action management with root cause analysis and effective corrective actions.
• Stay updated on evolving regulatory requirements and translate them into lifecycle process improvements.
• Serve as the primary SQA contact for digital process improvement and AI enablement initiatives.
• Manage automation and AI opportunity pipelines, prioritizing adoption to improve quality and compliance.
• Develop dashboards, compliance scorecards, and KPI reporting for visibility into compliance health and risks.
• Facilitate governance reviews and cross-functional discussions to ensure consistent quality and regulatory practices.
• Coach teams on lifecycle execution, CSA principles, validation, and risk management.

Kenntnisse

Process optimization

AI-enabled solutioning

Audit readiness

CAPA management

DevOps tools & pipelines

Regulatory audits/inspections

Quality monitoring solutions

Project management

Analytical skills

Documentation

Coaching / training

CSA / digital quality

GxP regulations

Ausbildung

Bachelor’s Degree in Engineering, Computer Science, Life Sciences, or related discipline

Master’s Degree

PhD

Tools

DevOps pipelines

Jobbeschreibung

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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.

Qualifications

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 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

• 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.

Additional Information

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

The compensation range described below 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 paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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, visit https://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