Principal Engineer, Quality - Automation and AI

Responsibilities

• Develop, implement, and champion solution/change strategies to align with organizational objectives and evolving regulatory requirements, leveraging AI-powered solutions and automation to enhance compliance monitoring and operational efficiency.
• Apply DevOps toolchain expertise (as appropriate) to ensure a simplified, integrated approach to technology-process integration and support automated monitoring for audit and compliance.
• Drive modernization of communications channels, excellence in metrics management, and automation in audit support and Corrective and Preventive Action (CAPA) processes, leveraging AI-driven solutions for proactive quality oversight.
• Lead continuous improvement and digital enablement initiatives, promoting widespread adoption of automation, intelligent reporting, automated workflows, and advanced analytics across quality-assurance activities.
• Oversee SLC monitoring activities by establishing automated dashboards, alerts, and reporting solutions to deliver actionable insights and ensure audit readiness.
• Serve as the primary point of contact for communications on quality events, facilitating issue tracking, documentation, and resolution, with a focus on root cause analysis and timely corrective actions.
• Remain proactive to regulatory trends and best practices, updating SLC and compliance processes as needed.
• Represent SQA in quality/governance forums, communicate metric-based outcomes, audit findings, and process improvements to business partners and cross-functional stakeholders.
• Manage support for internal and external audits, overseeing audit readiness, CAPA processes, and documentation of remediation efforts.
• Provide expert mentorship on quality system automation, AI enablement, quality metrics, and cross-functional process optimization.
• Lead and deliver targeted training for internal staff and business units on digital quality enablement, compliance monitoring, metrics management, and audit support tools.
• Supervise documentation, evidence management, and reporting to sustain compliance and facilitate investigations and audit support.
• Support Center of Excellence (CoE) operations in SLC communications, newsletters, meeting coordination, and digital reporting initiatives.
• Respond to escalations and critical issues in quality monitoring, coordinating cross-functional resolution.
• Participate in infrastructure risk and change management, ensuring processes are appropriately documented and compliant.
• Develop, monitor, and report on SQA metrics using automated data analytics to drive insights, gap closure, and transparent executive reporting.
• Required:
• Bachelor's Degree with 7 years experience; Master's Degree with 6 years experience; PhD with 2 years experience
• Overall experience to include two of the following areas: Experience in a formal software development life cycle. Experience in regulated software environment. Software Quality experience, Project Management in software experience. Auditing Experience. Quality Systems experience.
• Strong experience in automation, pipeline technologies, workflow optimization, AI/ML solutions, and integration of DevOps tools to support communications and audit-readiness functions.
• Demonstrated success in cross-functional process improvement, risk management, audit support, and CAPA execution.
• Experience supporting regulatory audits/inspections and implementing quality monitoring solutions.
• Advanced project management, analytical, and documentation skills; ability to create and teach knowledge materials for diverse audiences.
• Ability to coach teams in policy, SLC execution, and regulatory requirements.
• Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary validation practices.
• Preferred:
• US regulations (GMP parts 11, 58, 210, 211, and 820). ASQ Certified CQA/CSQE.
• Supervisory experience.
• Professional certifications (e.g., ASQ CQA, PMP, Six Sigma).
• Applicable only to applicant

Additional Information

The Principal Quality Engineer - Automation and AI Enablement is responsible for ensuring that AbbVie's IT operations and software lifecycle processes fully comply with regulatory requirements and corporate standards. This role provides leadership in defining, implementing, and optimizing quality systems through digital enablement and AI-driven solutions, collaborating directly with cross-functional teams. Focusing on modernizing communications, metrics management, SLC monitoring activities, and providing end-to-end audit and Corrective and Preventive Action (CAPA) support, the incumbent leverages automation and AI to strengthen cross-functional integration and quality oversight. They drive improvement initiatives, support audit readiness, ensure effective issue tracking and resolution, deliver actionable insights through metrics and reporting, and act as the primary point of contact between business units and quality teams to maintain mutual understanding and effective service agreements.

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