Principal Engineer, Quality Automation and AI

The Principal Quality Engineer  Automation and AI Enablement is responsible for ensuring that AbbVies 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. 

Key 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. 

Qualifications :

Required:

• Bachelors Degree with 7 years experience; Masters 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 partsand 820). ASQ Certified CQA/CSQE.
• Supervisory experience.
• 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 or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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 visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time