Senior Specialist, QA IT

AstraZeneca plc; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

AstraZeneca plc is seeking a Senior Specialist, QA IT to provide independent QA oversight for GxP computerised systems across their lifecycle. You will partner with process owners, IT, Digital, Data and suppliers to ensure solutions are compliant, secure and reliable.

You will apply regulatory requirements, AstraZeneca standards and industry best practice to enable validated delivery, operation, changes and retirement of technology used in regulated activities.

Qualifications

• Provides QA oversight for GxP computerised systems across their lifecycle.
• Approves intended use, GxP impact, risk assessments and validation/assurance plans.
• Ensures data integrity controls meet ALCOA++ principles including access control and audit trails.
• Oversees incidents, deviations, CAPAs, changes and supplier issues.
• Escalates risks with independent Quality decisions and clear communication.

Responsibilities

• Acts as QA IT lead for assigned GxP systems portfolio.
• Determines proportionate assurance pathway based on impact and complexity.
• Reviews architecture and control design from a Quality perspective.
• Assesses supplier capability and evidence, supports audits.
• Maintains validated state through monitoring, access reviews and patch assessment.
• Leads or supports investigations into significant system failures and data integrity concerns.
• Provides coaching to project teams on computerised-system assurance and inspection readiness.

Skills

QA oversight

GxP compliance

Lifecycle-based approach

Regulatory requirements

Data integrity (ALCOA++)

Audit readiness

Risk assessment

Stakeholder collaboration

Quality decision-making

Coaching and training

Job description

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
05-Nov-2026

Closing Date
18-Nov-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations