Senior Specialist, QA IT

About the role

AstraZeneca is looking for a Senior Specialist, QA IT who provides independent Quality Assurance oversight for GxP computerised systems and digital solutions across their lifecycle. The role partners with business process owners, system owners, IT, Digital, Data and external suppliers to ensure systems are fit for intended use, compliant, secure and reliable, and supported by proportionate, risk-based assurance. It applies regulatory requirements, AstraZeneca standards and industry good practice to enable compliant delivery, operation, change and retirement of technology used in regulated activities.

Key responsibilities

• Provide QA oversight and approval for GxP computerised systems and digital solutions using a lifecycle and risk-based approach.
• Review and approve intended use, GxP impact and risk assessments, validation or assurance plans, requirements, testing strategies, traceability, reports, release decisions and retirement records.
• Ensure data integrity controls meet ALCOA+ principles, including access, audit trails, electronic records and signatures, backup, recovery, retention, archival and data migration.
• Oversee incidents, deviations, CAPAs, changes, periodic reviews, supplier issues and other quality records linked to GxP technology.
• Challenge the adequacy of evidence, identify residual risk and make clear, timely and independent Quality decisions or escalations.
• Partner with system and process owners from design inception to embed compliance and avoid late-stage validation barriers.
• Support audits and regulatory inspections by keeping records complete, current, traceable and inspection-ready.
• Translate evolving regulatory expectations into practical guidance and proportionate controls.
• Contribute to process improvement, standardisation, reusable assurance patterns, metrics and capability building.
• Act as QA IT lead or subject matter expert for an assigned portfolio of GxP systems, platforms, projects or business functions, determining the proportionate assurance pathway.
• Review solution architecture and control design, assess supplier capability and evidence, and support supplier audits where required.
• Own the Computer System Inventory list and oversee all IT GxP systems.
• Provide QA oversight for agile, product-based and iterative delivery, and support digital technologies, automation, analytics and AI-enabled functionality in GxP processes.
• Maintain validated state through operational monitoring, access reviews, audit-trail review, periodic review, vulnerability or patch assessment, business continuity testing and controlled change.
• Lead investigations of significant system failures, data-integrity concerns and compliance events.
• Coach and train project teams, system owners and Quality colleagues, and represent QA IT in governance forums.