Senior Digital QA Engineer: Regulatory Compliance & AI
Regulatory Jobs
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Benefits offered by this job
Job summary
AbbVie is seeking a Principal Quality Engineer – Digital Regulatory Assurance to oversee regulatory quality for IT applications, infrastructure, and technology in a regulated life sciences environment. You will lead SLC/CSA activities, validation, and risk management, driving AI-enabled improvements and inspection readiness.
The role requires extensive experience with GxP, audits, and quality metrics, plus the ability to coach teams and advance a digital quality transformation across lifecycle
Qualifications
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related discipline; 7+ years experience, or Master’s with 6+ years, or PhD with 2+ years.
- Experience with CSA, digital transformation in quality, and validation practices.
- Strong knowledge of GxP regulations and regulatory audits/inspections.
- Proven ability to optimize processes, implement AI-enabled solutions, and drive quality improvements.
Responsibilities
- Provide regulatory quality oversight for GxP applications, infrastructure, and technology throughout the Software Lifecycle (SLC).
- Lead compliance monitoring, audits, health assessments, and quality metrics reporting.
- Partner with business and tech teams to embed validation and regulatory requirements into lifecycle activities.
- Drive CAPA, audit actions, and remediation planning with root cause analysis.
Skills
Education
Job description
AbbVie is seeking a Principal Quality Engineer – Digital Regulatory Assurance to oversee regulatory quality for IT applications, infrastructure, and technology in a regulated life sciences environment. You will lead SLC/CSA activities, validation, and risk management, driving AI-enabled improvements and inspection readiness.
The role requires extensive experience with GxP, audits, and quality metrics, plus the ability to coach teams and advance a digital quality transformation across lifecycle
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