Senior QA Specialist, IT

AstraZeneca

. Provide independent Quality Assurance oversight for GxP computerised systems and digital solutions throughout their lifecycle .

Posted 11/5/2026full-timeDublin • IrelandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Quality Assurance oversight for GxP computerised systems, ensuring compliance with regulatory requirements and ALCOA++ data integrity principles. Capable of providing independent quality decisions, coaching teams, and supporting audits while maintaining inspection-ready records.

Highest-signal resume keywords

Quality Assurance OversightGxP Computerised SystemsALCOA++ Data Integrity PrinciplesAgile Delivery ModelsRegulatory Compliance

ATS Keywords

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Hard Skills

Lifecycle Assurance ApproachesValidation PlansRisk AssessmentsIncident ManagementSupplier AuditsSolution ArchitectureControl DesignDigital TechnologiesData IntegrityCompliance Events Investigation

Soft Skills

CoachingCommunicationDecision-MakingCollaborationProblem-Solving

Tools & Technologies

Cloud ServicesAutomation ToolsAnalytics PlatformsAudit-Trail Review SystemsBusiness Continuity Testing Tools

Industry Keywords

GxPAstraZeneca StandardsGood PracticeCAPATraceabilityPeriodic ReviewsChange ManagementInspection ReadinessOperational MonitoringQuality Standards

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

Provide independent Quality Assurance oversight for GxP computerised systems and digital solutions throughout their lifecycle
Partner with business process owners, system owners, IT, Digital, Data and external suppliers
Review and approve intended use, GxP impact and risk assessments, assurance plans, requirements, testing strategies, traceability, reports, release decisions and retirement records
Ensure data integrity controls meet ALCOA++ principles
Provide Quality oversight of incidents, deviations, CAPAs, changes, periodic reviews and supplier issues
Identify residual risk and make independent Quality decisions or escalations
Build compliance into solutions from design inception and avoid late-stage validation barriers
Support audits and regulatory inspections by maintaining complete, current, traceable and inspection-ready records
Interpret evolving regulatory expectations and translate them into practical guidance and proportionate controls
Contribute to process improvement, standardisation, reusable assurance patterns, metrics and capability building across the QA IT community
Act as QA IT lead or subject matter expert for an assigned portfolio of GxP systems, platforms, projects or business functions
Determine proportionate assurance pathways based on intended use, impact, criticality, complexity, supplier controls and failure detectability
Review solution architecture and control design from a Quality perspective
Assess supplier capability and evidence and define reliance, oversight and change-notification expectations
Own the Computer System Inventory list for IT GxP systems
Provide QA oversight for agile, product-based and iterative delivery models
Support governance of digital technologies, automation, analytics and AI-enabled functionality in GxP processes
Ensure validated state is maintained through monitoring, access reviews, audit-trail reviews, periodic reviews, vulnerability or patch assessments, business continuity testing and controlled change
Lead or support investigations of significant system failures, data-integrity concerns and compliance events
Provide coaching and training to project teams, system owners and Quality colleagues
Represent QA IT in governance forums and communicate risks, evidence gaps, decisions and required actions

Requirements

What you’ll need

Senior-level experience in Quality Assurance oversight for GxP computerised systems and digital solutions
Knowledge of relevant regulatory requirements, AstraZeneca standards and recognised industry good practice
Experience applying lifecycle and risk-based assurance approaches
Knowledge of ALCOA++ data integrity principles
Experience with validation or assurance plans, requirements, testing strategies, traceability, reports, release decisions and retirement records
Experience overseeing incidents, deviations, CAPAs, changes, periodic reviews and supplier issues
Ability to assess residual risk and make independent Quality decisions or escalations
Knowledge of solution architecture, control design, interfaces, configurations, workflows, master data, reports, infrastructure dependencies and cloud services
Experience assessing supplier capability and evidence and supporting supplier audits
Knowledge of agile, product-based and iterative delivery models
Knowledge of objective evidence, traceability, segregation of duties and controlled release
Experience with digital technologies, automation, analytics and AI-enabled functionality in GxP processes
Knowledge of operational monitoring, access reviews, audit-trail review arrangements, periodic review, vulnerability or patch assessment, business continuity testing and controlled change
Experience investigating system failures, data-integrity concerns and compliance events
Ability to provide coaching and training on computerised-system assurance, data integrity and inspection readiness
Ability to communicate risk, evidence gaps, decisions and required actions to technical and non-technical stakeholders
Compliance with the AstraZeneca Code of Ethics, company policies, Quality standards and applicable GxP requirements

Benefits

Comp & perks

Reasonable adjustments/accommodations to help all candidates perform at their best
Inclusive and equitable recruitment process
Support for candidates with adjustments/accommodations needs