Senior Manager, Software Quality Engineering

Company Description

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

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.

• 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, Dev Ops, 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 improvement programs, including shift‑left testing, risk‑based validation, automation, and process simplification.
• Responsible for ensuring compliance with Corporate and Divisional policies, standards, and governance; evaluate solution alternatives using standard IS methodologies and assess regulatory impacts.
• Lead integration efforts with BTOs/BTS teams, maintain strong cross‑functional relationships, broker services, manage interdependencies, and support customer engagement.
• Lead a significant area of work with technical, financial, and quality accountability; establish objectives, delegate assignments, develop talent, and deliver training and awareness on compliant quality engineering and regulatory changes.

• Bachelor's Degree with 8 years experience;
  Master's Degree with 7 years experience;
  PhD with 3 years experience.
• Exercises latitude in the approach to problem solving.
• Work checked through consultation and agreement with others rather than formal review by superiors.
• Familiarity with key regulatory domains (GxP, SOX, PCI, Privacy, Toxins, Security, Cybersecurity, NIS2, AI, Accessibility, etc).
• Experience with controls frameworks

• Experience working across multiple business areas within BTS/BTO.
• Experience supporting audits/inspections and leading CAPA remediation.
• Experience driving automation, compliance modernization, or validation transformation programs.

• 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…