Global QMS & Smart Release Lead (AI-Enabled)

AstraZeneca; Dublin; On-site; EUR 150,000 - 190,000; Full time

Job summary

AstraZeneca seeks a senior Quality leader to own the global Quality Management System (QMS) and governance for the Rare Disease Unit. You will drive Smart Release adoption, improve processes, and ensure readiness for inspections across multiple Ireland sites, including Dublin, Athlone and Cork.

Role requires extensive global quality leadership, CAPA/change control, and data integrity expertise, with a strong emphasis on AI-enabled risk-based review and continuous improvement.

Qualifications

• Extensive senior Quality leadership in a global, highly regulated biopharmaceutical setting.
• Proven leadership of global Quality Systems and Complaints, including regulatory inspections.
• Led a comparable shift: global process simplification or release redesign through a matrix.
• Enough data and AI fluency to shape use cases and challenge AI outputs.

Responsibilities

• Own the Smart Release vision, target process, roadmap, business case and benefits, as part of the integrated transformation roadmap.
• Translate customer and Quality Operations needs into prioritised process, data, technology and control requirements, and lead redesign and adoption with the teams affected.
• Track benefits such as release cycle time, right-first-time, exception resolution, capacity and supply reliability, and prioritise further simplification and automation by risk and value.
• Own and continuously improve the operating model of QMS + Smart Release.

Skills

Senior Quality leadership

Global Quality Systems

AI fluency

Regulatory inspections

Education

Bachelor's degree in Pharmacy, Science, or Engineering

Tools

QMS software

Job description

AstraZeneca seeks a senior Quality leader to own the global Quality Management System (QMS) and governance for the Rare Disease Unit. You will drive Smart Release adoption, improve processes, and ensure readiness for inspections across multiple Ireland sites, including Dublin, Athlone and Cork.

Role requires extensive global quality leadership, CAPA/change control, and data integrity expertise, with a strong emphasis on AI-enabled risk-based review and continuous improvement.