Senior Manager, Software Quality Engineering

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Leads the strategic integration of Software Quality Assurance (SQA), Compliance, and BTS Technology Enablement teams delivering the Technology Solution Lifecycle (TSL) automation tools. Responsible for ensuring pharmaceutical regulatory requirements (GxP, CSV, Part 11, Annex 11) are accurately interpreted, translated, and embedded into technology practices and CI/CD pipelines. Accountable for identifying strategic business opportunities, shaping compliant technology solutions, leading process modernization, and ensuring alignment of digital quality engineering with business and regulatory expectations across multiple business areas. 

Responsibilities

•  Lead as the primary liaison between SQA and Compliance leaders and BTS technology enablement teams; broker services, align stakeholders, and resolve interdependencies across multiple business areas. 
• Responsible for analyzing business strategies, processes, and regulatory drivers across business units to identify needs and opportunities for quality and compliance improvement enabled by technology. 
• Accountable for interpreting and translating compliance and quality requirements (GxP, CSV, Part 11, Annex 11, SLC) into epics, user stories, acceptance criteria, functional specifications, and process changes. 
• Lead development, maintenance, and validation of traceability matrices linking requirements, controls, system design, and verification evidence; ensure inspection-ready documentation. 
• Partner with development, DevOps, and automation teams to embed compliant quality controls into TSL tools, including risk profiling, requirements/design management, CI/CD, testing, deployment, and monitoring. 
• Lead significant cross-functional i