Senior Digital Regulatory Assurance Engineer

AbbVie

United States

On-site

USD 130,000 - 180,000

Full time

4 days ago

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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.