Senior Principal Quality Engineer, Digital Regulatory & AI

AbbVie; North Chicago (IL); In loco; USD 140.000 - 190.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Descrizione del lavoro

AbbVie seeks a Principal Quality Engineer – Digital Regulatory Assurance to provide regulatory oversight for IT applications, infrastructure platforms, and tech solutions in a regulated life sciences environment. You will lead SLC/CSA practices, validation, and risk management while modernizing quality processes with automation and AI-driven metrics.

You will drive governance, CAPAs, audit readiness, and executive reporting, partnering with business and tech teams to ensure compliant design,

Competenze

• 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.
• Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary validation practices.
• Expert knowledge of GxP regulations required.

Mansioni

• Provide quality and regulatory oversight for GxP-relevant applications, infrastructure platforms, and technology solutions throughout the Software Lifecycle (SLC).
• Act as a trusted advisor on SLC, CSA, validation, infrastructure qualification, risk management, and regulatory compliance.
• Lead audit and inspection readiness efforts, including preparation activities, evidence reviews, and remediation planning.
• Develop and maintain quality dashboards, compliance scorecards, and executive reporting.
• Coach and mentor teams on lifecycle execution, CSA principles, validation expectations, and quality risk management.

Descrizione del lavoro

AbbVie seeks a Principal Quality Engineer – Digital Regulatory Assurance to provide regulatory oversight for IT applications, infrastructure platforms, and tech solutions in a regulated life sciences environment. You will lead SLC/CSA practices, validation, and risk management while modernizing quality processes with automation and AI-driven metrics.

You will drive governance, CAPAs, audit readiness, and executive reporting, partnering with business and tech teams to ensure compliant design,