Position Summary
The Director, Digital & IT Quality is responsible for leading 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, and maintained in accordance with applicable GxP, data integrity, quality risk management, computerised system 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.
Principal Responsibilities
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, GxP impact assessment, risk classification, design assurance, validation, deployment, monitoring, change control, periodic review, and retirement.
Establish and maintain risk-based quality governance for agentic AI capabilities, including human oversight, agent behaviour monitoring, 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 for GxP applicability, 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 for computerised system 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 and monitor ongoing 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 to GxP IT, 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 by identifying opportunities 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 capability required to 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 Quality GxP oversight for IT operations, digital systems, computerised system 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, GxP computerised systems, and emerging expectations for responsible AI and AI lifecycle governance.
- Strong understanding of IT quality systems, digital platforms, AI/ML and generative AI capabilities, agentic AI concepts, quality assurance methodologies, risk-based validation, lifecycle monitoring, and quality governance operating models.
- Demonstrated success in audit support, inspection readiness, quality risk management, continuous improvement, and implementation of effective controls for regulated IT, digital, data, or AI-enabled systems.
- Experience establishing or 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 to operate efficiently 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 to represent the company and to negotiate at different levels contacts both internally and externally.
- Strong verbal and written communication skills with well-structured communication and presentation ability to various 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, or a related discipline. Advanced qualification or demonstrable continuing professional development in AI governance, digital quality, data integrity, computerised system validation, computer software assurance, or quality risk management is desirable.
Date Posted
21-Jul-2026
Closing Date
03-Aug-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, please complete the section in the application form.
