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Global Quality Senior Director, AI Quality AssuranceAstraZeneca · US - Gaithersburg - MD
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AstraZeneca

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Global Quality Senior Director, AI Quality Assurance

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🗓️ Posted 2026-08-20 US - Gaithersburg - MD Full-time Hybrid Manufacturing Transport Logistics
💰 Salary Not shared 📊 Market 18,000 GBP–28,000 GBP/mo

About the Company

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 defen

Requirements

  • ● Bachelors' degree in a science / technical field such as Pharmacy, Biology, Chemistry.
  • ● + 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.
  • ● Recognised expertise and credibility to act as an AstraZeneca representative.
  • ● PhD or higher education is preferred.
  • ● Project management experience in PM, lead and governance roles.
  • ● 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 our unique and ambitious world.
  • ● Why AstraZeneca:
  • ● Here, ambitious science meets disciplined execution. You will work with cutting-edge digital technologies alongside experts from manufacturing, quality, data and engineering-teams that come together to turn complex ideas into reliable outcomes for patients. We value kindness alongside ambition, encouraging people to step up, lead and learn as they build long-term, globally varied careers. With strong investment and clear direction, you will help shape how AI safely accelerates the journey from molecule to medicine while growing your own influence and expertise.
  • ● If you are ready to set global standards for AI in GxP and turn vision into inspected, scalable reality, seize this opportunity to lead impact that will be felt by patients and colleagues around the world
  • ● The annual base pay (or hourly rate of compensation) for this position ranges from 207,249 to 310,974. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
  • ● Date Posted 20-Aug-2026
  • ● Closing Date 30-Aug-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.