Global Quality Senior Director, AI Quality Assurance

About this role

Are you ready to define how AI is designed, governed and inspected within GxP across a global manufacturing and quality network? Can you turn emerging technologies into compliant, scalable solutions that safeguard patients and accelerate reliable supply?   Based in Gaithersburg, US, this role sets the global agenda for AI in Quality Assurance, ensuring our use of AI within GMP-regulated and adjacent processes is ethical, transparent and inspection-ready. You will translate strategy into standards and measurable outcomes, aligning the network on one way of working while enabling speed and innovation. Reporting into Central Quality leadership, you will build confidence with regulators, partner with digital and IT leaders, and equip our people to use AI responsibly to improve consistency, efficiency and decision-making at scale.   Accountabilities: • AI Quality Strategy and Governance: Define, drive and continuously evolve the global AI quality strategy for GxP and GxP-adjacent use cases; own AI quality standards and global GMP documents that set interpretation and application expectations for AstraZeneca. • GxP AI Guidance and Compliance: Interpret and define requirements for AI in GMP-regulated processes and systems; deploy practical guidance and controls that balance license-to-operate with efficiency and productivity. • Inspection Readiness and Defense: Lead internal auditor training on AI use; set inspection readiness plans for AI-focused assessments; host and defend inspections; drive successful outcomes as defined by inspection results and manage observation responses in line with cGMP and ICH. • Business Process Ownership: As Global Quality Business Process Owner, design and own global standards and procedures; ensure procedures meet regulatory requirements and reflect cGMP; define global KPIs, monitor and improve performance; manage interdependencies with other processes and BPOs. • Quality IT Systems Oversight: Ensure supporting Quality IT systems meet regulatory and GxP requirements; manage business requirements and BAU processes with the IT system owner; approve system changes and releases into production to maintain validated, compliant states. • Global Network Leadership: Engage and lead a matrixed global process network; provide subject-matter expertise, coaching and training materials; drive global standardization and simplification; facilitate sharing and adoption of good practices and learning; build capability across teams. • Cross-Functional Delivery of AI Solutions: Lead cross-functional teams to deliver and scale AI in QC testing, process monitoring, data analytics and risk-based QA; identify and evaluate technology vendors and research partners; serve as the primary point of contact for AI-related QA/QC projects and external collaborations. • Performance Monitoring and Continuous Improvement: Monitor trends and signals across audits, issues, deviations, complaints and performance data; apply Lean to process design and execution; prioritize and execute global change programs that improve compliance, robustness and throughput. • External Influence and Thought Leadership: Engage and influence external groups and industry bodies to anticipate regulatory and technological shifts; incorporate emerging thinking into quality planning and strategic development; set institutional and industry standards where appropriate. • Measurement and Reporting: Monitor and report the effectiveness of the quality function for AI globally and regionally; communicate outcomes, impact and value to executive leadership; ensure alignment and achievement of shared goals.

Essential Skills/Experience: • Bachelors' degree in a science / technical field such as Pharmacy, Biology, Chemistry. • 10+ years of experience in quality delivery within a pharmaceutical manufacturing environment • Extensive experience in multiple areas of quality delivery within a pharmaceutical manufacturing environment. • Extensive experience in leading and managing Quality Systems at a site / regional / global level. • Demonstrated leadership experience across the quality organisation. • Experience having led large-scale change initiatives from planning to implementation. • Experience working with regulatory / SOP / GxP requirements and driving compliance across teams. • Experience in co-working with cross-functional global leadership and other senior stakeholders. • Experience working across boundaries – internally, cross-functionally, externally, internationally, and cross-culturally. • Recognised expertise and credibility to act as an AstraZeneca representative. • Experience in leading transformational change programs across global Quality and Operations networks.  

Desirable Skills/Experience: • PhD or higher education is preferred. • Experience with major regulators (FDA, MHRA, EMA). • Experience with DAI or similar decision-making processes and models. • Experience with Business Process Management. • Project management experience in PM, lead and governance roles. • Experience with global IT GMP Quality system delivery and lifecycle management. • Training and certification in Lean, Six Sigma and similar recognized industry continuous improvement programs. • Strong business acumen and ability to assess trends, complex data sets and generate robust business cases and impact analysis. • Knowledge of data privacy, ethical AI principles, and risk management in QA/QC. • Strategic mindset with ability to anticipate trends and opportunities for AI in quality assurance and control.  

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in o

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