Senior Software Quality Engineer
About The Position
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 . The Associate Business Systems Consultant supports the integration of Business Technology Solutions (BTS), Software Quality Assurance (SQA), Compliance, and Technology Enablement teams in delivering solutions aligned to the Technology Solution Lifecycle (TSL). The role assists in interpreting and translating pharmaceutical regulatory requirements (GxP, CSV, Part 11, Annex 11) and ensuring they are embedded into technology practices and CI/CD pipelines. Supports identification of 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.
Requirements
- Bachelor’s Degree with 6 years’ experience; Master’s Degree with 5 years’ experience; PhD with 0 years’ experience
- Experience with Azure, GitHub, AWS
- Experience with writing requirements for JIRA
- Experience with Service Now CMDB and Change Management
- Experience with writing agentic AI requirements
- Experience with translating regulatory needs for implementing technical components
Responsibilities
- Support liaison activities between SQA, Compliance, and BTS technology enablement teams; help broker services, facilitate stakeholder alignment, and surface interdependencies for resolution.
- Assist in analyzing business strategies, processes, and regulatory drivers to identify opportunities for improving quality, compliance, and process efficiency enabled by technology.
- Support the interpretation and translation of compliance and business requirements (GxP, CSV, Part 11, Annex 11, SLC) into user stories, acceptance criteria, functional requirements, and process updates.
- Contribute to the development, maintenance, and validation of traceability matrices linking requirements, controls, system design elements, and verification evidence; ensure documentation is accurate and inspection-ready.
- Collaborate with development, DevOps, and automation teams to support embedding compliant quality controls into TSL tools, including requirements/design management, testing, CI/CD workflows, deployment, and monitoring.
- Assist cross-functional teams in implementing improvement programs including shift-left testing, risk-based validation, automation, and process simplification.
- Support compliance with Corporate and Divisional policies, standards, and governance; assist in evaluating solution alternatives using standard IS methodologies and identifying regulatory impacts.
- Coordinate with BTOs and BTS teams to support integration efforts, maintain cross-functional relationships, and ensure effective engagement and communication.
- Participate in delivering training and awareness activities on compliant quality engineering practices, requirements, and regulatory updates.
- Assist with audit and inspection readiness activities; support document preparation, evidence collection, and remediation.
Benefits
- 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 short-term incentive programs.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
