Senior Software Quality Engineer

Role Summary

The Senior Software Quality Engineer will support the integration of Business Technology Solutions (BTS), Software Quality Assurance (SQA), Compliance, and Technology Enablement teams to deliver solutions aligned to the Technology Solution Lifecycle (TSL). They interpret and translate pharmaceutical regulatory requirements (GxP, CSV, Part 11, Annex 11, SLC) into technology practices and CI/CD pipelines and help ensure these controls are embedded across programs. The role involves identifying strategic opportunities, shaping compliant technology solutions, leading process modernization, and aligning digital quality engineering with business and regulatory expectations across multiple business areas. The engineer collaborates with cross-functional teams to implement quality controls, training, and audit readiness.

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.

Qualifications

• 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