AstraZeneca

3 days ago

Director, AI & Digital Quality

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 6 hours agoStatus: Live

Job Summary

Lead a team of quality professionals to provide Quality Assurance oversight for IT, digital systems, data platforms, automation, and AI/ML—including emerging agentic AI capabilities. Ensure digital and AI-enabled solutions are developed, validated, deployed, monitored, and maintained under GxP, data integrity, cybersecurity, and responsible AI governance expectations. Partner across IT, Digital, Data Governance, Business Quality, system/model owners, suppliers, and stakeholders to keep systems inspection ready and protect patient safety and product quality.

Location: Dublin

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Director level

Key Responsibilities

•Lead, coach, and develop a team of quality professionals to provide QA oversight across IT, digital quality, data, automation, AI/ML, and agentic AI systems in a regulated environment.
•Provide QA oversight across the full lifecycle of digital and AI-enabled solutions, including 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 behavior monitoring, boundaries, knowledge grounding, auditability, traceability, escalation pathways, and controls to prevent uncontrolled autonomous actions.
•Ensure AI/ML, generative AI, and agentic AI solutions are assessed for GxP applicability, patient safety, product quality, data integrity, regulatory decision impact, cybersecurity risk, privacy, and supplier/vendor risk.
•Maintain inspection readiness by ensuring complete, accurate, and retrievable evidence of intended use, risk decisions, validation, approvals, human oversight, monitoring, periodic review, supplier qualification, and management review.

Key Requirements

•15+ years in pharmaceutical, biotechnology, life sciences, or similarly regulated industries with increasing responsibility in Quality Assurance, IT Quality, Digital Quality, Quality Systems, or governance functions.
•10+ years providing operational QA and/or Quality GxP oversight for IT operations, digital systems, computerized system validation/computer software assurance, data platforms, automation, AI/ML, or emerging AI-enabled technologies.
•Strong awareness of pharmaceutical quality, regulatory expectations, inspection readiness, data integrity, GxP, computerized systems, and responsible AI governance expectations.
•Strong understanding of IT quality systems, digital platforms, AI/ML and generative AI, agentic AI concepts, quality assurance methodologies, risk-based validation, lifecycle monitoring, and quality governance operating models.
•Demonstrated success supporting audits/inspections, managing quality risk, driving continuous improvement, and implementing effective controls for regulated digital, data, or AI-enabled systems.

Experience:PharmaceuticalsBiotechnologyLife sciencesRegulated industry

Skills:LeadershipCoachingCommunicationStakeholder managementLeadership influencing

Tech Stack:AI/MLArtificial intelligenceMachine learningGenerative AIAgentic AIDigital qualityData platformsAutomationGxPData integrityComputerised system validationComputer software assuranceCybersecurityData governance

Company Brief

AstraZeneca

Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.

Industry: Pharmaceuticals

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Cambridge, United Kingdom

Founded: 1999

Glassdoor: 3.8

Website LinkedIn

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AstraZeneca

3 days ago

Director, AI & Digital Quality

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 6 hours agoStatus: Live

Job Summary

Location: Dublin

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Director level

Key Responsibilities

•Lead, coach, and develop a team of quality professionals to provide QA oversight across IT, digital quality, data, automation, AI/ML, and agentic AI systems in a regulated environment.
•Provide QA oversight across the full lifecycle of digital and AI-enabled solutions, including 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 behavior monitoring, boundaries, knowledge grounding, auditability, traceability, escalation pathways, and controls to prevent uncontrolled autonomous actions.
•Ensure AI/ML, generative AI, and agentic AI solutions are assessed for GxP applicability, patient safety, product quality, data integrity, regulatory decision impact, cybersecurity risk, privacy, and supplier/vendor risk.
•Maintain inspection readiness by ensuring complete, accurate, and retrievable evidence of intended use, risk decisions, validation, approvals, human oversight, monitoring, periodic review, supplier qualification, and management review.

Key Requirements

•15+ years in pharmaceutical, biotechnology, life sciences, or similarly regulated industries with increasing responsibility in Quality Assurance, IT Quality, Digital Quality, Quality Systems, or governance functions.
•10+ years providing operational QA and/or Quality GxP oversight for IT operations, digital systems, computerized system validation/computer software assurance, data platforms, automation, AI/ML, or emerging AI-enabled technologies.
•Strong awareness of pharmaceutical quality, regulatory expectations, inspection readiness, data integrity, GxP, computerized systems, and responsible AI governance expectations.
•Strong understanding of IT quality systems, digital platforms, AI/ML and generative AI, agentic AI concepts, quality assurance methodologies, risk-based validation, lifecycle monitoring, and quality governance operating models.
•Demonstrated success supporting audits/inspections, managing quality risk, driving continuous improvement, and implementing effective controls for regulated digital, data, or AI-enabled systems.

Experience:PharmaceuticalsBiotechnologyLife sciencesRegulated industry

Skills:LeadershipCoachingCommunicationStakeholder managementLeadership influencing

Company Brief

AstraZeneca

Industry: Pharmaceuticals

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Cambridge, United Kingdom

Founded: 1999

Glassdoor: 3.8

Website LinkedIn