Job Description / Role Capsule

The Senior Specialist, QA IT 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, reliable and supported by proportionate, risk-based assurance. The role applies relevant regulatory requirements, AstraZeneca standards and recognised industry good practice to enable compliant delivery, operation, change and retirement of technology used in regulated activities.

Typical Accountabilities

• Provides QA oversight and approval for GxP computerised systems and digital solutions, applying a lifecycle and risk-based approach.
• Reviews and approves intended use, GxP impact and risk assessments, validation or assurance plans, requirements, testing strategies, traceability, reports, release decisions and retirement records.
• Ensures data integrity controls meet ALCOA++ principles, including appropriate access, audit trails, electronic records and signatures, backup, recovery, retention, archival and data migration controls.
• Provides Quality oversight of incidents, deviations, CAPAs, changes, periodic reviews, supplier issues and other quality records associated with GxP technology.
• Challenges the adequacy of evidence, identifies residual risk and makes clear, timely and independent Quality decisions or escalations.
• Partners with system owners, process owners and technical teams from design inception to build compliance into solutions and avoid late-stage validation barriers.
• Supports audits and regulatory inspections by ensuring records are complete, current, traceable and inspection-ready.
• Interprets evolving regulatory expectations and industry practice, and translates them into practical guidance and proportionate controls.
• Contributes to process improvement, standardisation, reusable assurance patterns, metrics and capability building across the QA IT community.
• Conducts all activities in accordance with the AstraZeneca Code of Ethics, company policies, Quality standards and applicable GxP requirements.

Specific Responsibilities of the Role Holder

• Acts as QA IT lead or subject matter expert for an assigned portfolio of GxP systems, platforms, projects or business functions.
• Determines the proportionate assurance pathway based on intended use, patient and product impact, process criticality, technical complexity, supplier controls and detectability of failure.
• Reviews solution architecture and control design from a Quality perspective, including interfaces, configurations, workflows, master data, reports, infrastructure dependencies and cloud services.
• Assesses supplier capability and evidence, supports supplier audits where required, and defines appropriate reliance, oversight and change-notification expectations.
• Owner of Computer System Inventory list for control and oversight of all IT GxP systems.
• Provides QA oversight for agile, product-based and iterative delivery models while ensuring objective evidence, traceability, segregation of duties and controlled release.
• Supports implementation and governance of digital technologies, automation, analytics and AI-enabled functionality when used in GxP processes, escalating to specialist AI assurance where appropriate.
• Ensures validated state is maintained through operational monitoring, access reviews, audit-trail review arrangements, periodic review, vulnerability or patch assessment, business continuity testing and controlled change.
• Leads or supports investigation of significant system failures, data-integrity concerns and compliance events, ensuring root cause, impact, remediation and effectiveness checks are robust.
• Provides coaching and training to project teams, system owners and Quality colleagues on computerised-system assurance, data integrity and inspection readiness.
• Represents QA IT in governance forums and communicates risk, evidence gaps, decisions and required actions clearly to technical and non-technical stakeholders.

Date Posted

Closing Date