Principal Engineer, Quality - Automation and AI

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The Principal Quality Engineer Automation and AI Enablementis responsible forensuring that AbbVie's IT operations and software lifecycle processes fullycomply withregulatory requirements and corporate standards. This role provides leadership in defining, implementing, andoptimizingquality 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 tomaintainmutual understanding and effective service agreements.

Key Responsibilities

• Develop, implement, and champion solution/change strategies to align with organizationalobjectivesand evolving regulatory requirements,leveragingAI-powered solutions and automation to enhance compliance monitoring and operational efficiency.
• Apply DevOps toolchainexpertise(asappropriate)to ensure a simplified, integrated approach to technology-process integration and support automated monitoring for audit and compliance.
• Drivemodernization of communications channels, excellence in metrics management, and automation in audit support and Corrective and Preventive Action (CAPA) processes,leveragingAI-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 byestablishingautomated 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,facilitatingissue tracking, documentation, and resolution, with a focus on root cause analysis andtimelycorrective 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 andfacilitateinvestigations 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.
  
  
  

Qualifications

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 materialsfordiverse 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

• Experience in a formal software development life cycle in life sciences industry.
• US regulations (GMP parts 11, 58, 210, 211, and 820). ASQ Certified CQA/CSQE.
• Supervisoryexperience.
• Professional certifications (e.g., ASQ CQA, PMP, Six Sigma).
  
  
  

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.
  
  
  

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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https://www.abbvie.com/join-us/reasonable-accommodations.html