AbbVie · 1 day ago
Senior Software Quality Engineer
AbbVie is a company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Senior Software Quality Engineer will support the integration of Business Technology Solutions and Software Quality Assurance teams, ensuring compliance with regulatory requirements and improving quality and process efficiency.
BiotechnologyFinanceHealthcarePharmaceuticalVenture CapitalFinancial ServicesHealth CareMedical
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
Qualification
Required
Bachelor's Degree with 6 years' experience; Master's Degree with 5 years' experience; PhD with 0 years' experience
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Recent News
Labiotech UG
2026-02-07
Pharma Letter
2026-02-06
Company data provided by crunchbase