The Director, Digital & IT Qualityis responsible forleading a team of quality professionals providing Quality Assurance oversight across IT, digital systems, data platforms, automation, artificial intelligence, machine learning, and emerging agentic AI capabilities. This role ensures that digital and AI-enabled solutions are developed,validated, deployed,monitored, andmaintainedin accordance withapplicableGxP, data integrity, quality risk management,computerisedsystem validation/computer software assurance, cybersecurity, supplier oversight, and responsible AI governance expectations. The Director provides strategic quality leadership to ensure systems are fit for intended use, appropriately risk assessed, under effective lifecycle control, and inspection ready. Through close partnership with IT, Digital, Data Governance, Business Quality, system owners, model owners, suppliers, and cross-functional stakeholders, this role enables compliant, scalable, and value-adding digital transformation while maintaining patient safety, product quality, data integrity, and a strong One-Quality culture.
PrincipalResponsibilities
Lead, coach, and develop a team of quality professionals responsible for QA oversight of IT, digital quality, data, automation, AI/ML, and agentic AI-enabled systems in a regulated environment.
Provide Quality Assurance oversight for the full lifecycle of digital and AI-enabled solutions, including concept, intended use,GxPimpact assessment, risk classification, design assurance, validation, deployment, monitoring, change control, periodic review, and retirement.
Establish andmaintainrisk-based quality governance for agentic AI capabilities, including human oversight, agentbehaviourmonitoring, tool and workflow boundaries, knowledge grounding, auditability, traceability, escalation pathways, and controls to prevent uncontrolled autonomous actions.
Ensure AI/ML, generative AI, and agentic AI solutions are appropriately assessed forGxPapplicability, patient safety, product quality, data integrity, regulatory decision-making impact, cybersecurity risk, privacy considerations, and supplier/vendor risk.
Oversee the development and maintenance of AI and digital quality governance frameworks, standards, procedures, working documents, templates, inventories, and training materials to enable consistent, inspectable, and scalable adoption.
Partner with IT, Digital, Data Governance, Cybersecurity, Privacy, Legal, Procurement, Business Quality, system owners, model owners, and suppliers to embed quality requirements into digital product lifecycles and operating models.
Provide QA oversight forcomputerisedsystem validation and computer software assurance activities, including regulatory impact determinations, requirements, risk assessments, validation planning, testing strategy, traceability, deployment readiness, and validation closure.
Ensure data integrity principles are applied to digital and AI-enabled systems, including data ownership, critical data identification, lineage, metadata, data quality, access controls, audit trails, versioning, retention, and controlled datasets used for training, validation, and operation.
Define andmonitorongoing controls for AI-enabled systems, including model performance, reliability, drift or degradation, bias, hallucination risk, explainability, retraining triggers, incident/problem management, and change management.
Maintain inspection readiness for IT, digital, and AI governance by ensuring complete,accurate, and readily retrievable evidence of intended use, risk decisions, validation, approvals, human oversight, monitoring, periodic review, supplier qualification, and management review.
Participate in and support Health Authority inspections, internal audits, supplier audits, and regulatory intelligence activities related toGxPIT, digital systems, AI, automation, and emerging technologies.
Develop, track, and report quality metrics and governance dashboards for digital and AI oversight, including system health, validation status, inventory accuracy, change performance, incidents, periodic reviews, model monitoring, and inspection readiness indicators.
Drive continuous improvement and digital quality maturity byidentifyingopportunities to simplify processes, strengthen controls, improve user adoption, and enable responsible innovation while protecting compliance and patient safety.
Manage departmental resources and budget, recommend strategic business plans, and ensure the function has the skills, capacity, and capabilityrequiredto support current and future digital, IT, and AI quality demands.
Qualifications
• Minimum 15 years of experience in the pharmaceutical, biotechnology, life sciences, or similarly regulated industry, with increasing levels of responsibility in Quality Assurance, IT Quality, Digital Quality, Quality Systems, or related governance functions.
• Minimum 10 years of experience providing operational QA and/or QualityGxPoversight for IT operations, digital systems,computerisedsystem validation/computer software assurance, data platforms, automation, AI/ML, or emerging AI-enabled technologies.
• Strong awareness and understanding of pharmaceutical quality, regulatory expectations, inspection readiness, data integrity,GxPcomputerisedsystems, and emerging expectations for responsible AI and AI lifecycle governance.
•Strong understanding of IT quality systems, digital platforms,AI/MLandgenerative AI capabilities, agentic AI concepts,quality assurance methodologies, risk-based validation, lifecycle monitoring, and quality governance operating models
•Demonstratedsuccess in audit support,inspectionreadiness, quality risk management, continuous improvement, and implementation of effective controls for regulated IT, digital, data, or AI-enabled systems.
• Experienceestablishingor operating governance for AI-enabled solutions, including AI inventories, intended use documentation, risk classification, human oversight, model monitoring, change control, incident/problem management, and lifecycle evidence.
• Knowledge of controls relevant to agentic AI, including bounded autonomy, human-in-the-loop or human-on-the-loop oversight, workflow orchestration, tool access controls, knowledge grounding, explainability, output verification, audit trails, and prevention of uncontrolled autonomous actions.
• Practical understanding of data governance and data integrity expectations for digital and AI systems, including data quality, lineage, metadata, ownership, critical data, access controls, audit trails, versioning, and retention.
• Ability to translate evolving regulatory, industry, and enterprise AI expectations into pragmatic quality processes, procedures, training, metrics, and inspection-ready evidence.
• Ability tooperateefficiently in a complex matrix organization and international environment.
• Ability to deal with external parties towards delivery of agreed requirements.
• Management skills for the development of a team of strong experts.
• Strong mature leadership and interpersonal influencing skills.
• Ability torepresentthe company and to negotiate at differentlevelscontacts both internally and externally
• Strong verbal and written communication skills with well-structured communication and presentation ability tovarious audience levels
•Proven experience in managing and developing cross-functional teams.
•Ability to manage department budget
Education
Academic degree in natural or applied sciences, pharmacy, chemistry, biotechnology, engineering, computer science, data science, information technology, quality management, ora relateddiscipline. Advanced qualification or demonstrable continuing professional development in AI governance, digital quality, data integrity,computerisedsystem validation, computer software assurance, or quality risk management is desirable.
Date Posted
21-Jul-2026
Closing Date
03-Aug-2026Our 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, please complete the section in the application form.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community. We are driven by a mission to change what it means to live with a rare disease.
A leader in rare disease for more than three decades and today continues to build a diversified pipeline across disease areas with significant unmet need, using an array of innovative modalities.
As part of AstraZeneca, Alexion is continually expanding its global geographic footprint to serve more rare disease patients around the world. It is headquartered in Boston, US.
Alexion’s pioneering legacy in rare disease is rooted in being the first to translate the complex biology of the complement system into novel medicines. Alexion pushes boundaries to accelerate discovery of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the world and continues to expand its reach to benefit more people globally.
GL/NP/0116
GL/NP/0095
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