Senior Software Quality Engineer at Abbvie

Key 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.