Senior Digital QA & Regulatory Assurance Engineer

AbbVie Inc.

Chicago, Northern (IL, KY)

Hybrid

USD 150,000 - 190,000

Full time

3 days ago
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Benefits offered by this job

Paid time off
Medical/Dental/Vision Insurance
401(k)

Job summary

AbbVie is seeking a Principal Quality Engineer in Chicago to provide regulatory assurance and quality oversight for IT applications and infrastructure within a regulated life sciences environment.

The role focuses on modernizing quality processes through automation, data-driven monitoring, dashboards, and AI-enabled solutions to strengthen inspection readiness and improve compliance across the Software Lifecycle.

Qualifications

  • Bachelor’s Degree with 7 years' experience; OR Master’s with 6 years' experience; OR PhD with 2 years' experience.
  • Experience with process optimization, AI-enabled solutions, audit readiness, CAPAs and DevOps tooling.
  • 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 (SLC).
  • Lead compliance monitoring activities across assigned portfolios, including audits and lifecycle health reporting.
  • Partner with business and technology teams to ensure quality, compliance, and validation requirements are built into design and deployment.

Skills

SLC & CSA knowledge
Regulatory compliance
Quality risk management
Leadership & mentoring
Communication

Education

Bachelor’s degree in Engineering/CS/Life Sciences
Master’s degree in related field
PhD in related field

Tools

DevOps tools
Pipeline technologies

Job description

AbbVie is seeking a Principal Quality Engineer in Chicago to provide regulatory assurance and quality oversight for IT applications and infrastructure within a regulated life sciences environment.

The role focuses on modernizing quality processes through automation, data-driven monitoring, dashboards, and AI-enabled solutions to strengthen inspection readiness and improve compliance across the Software Lifecycle.

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