Director, Head of Quality Management Systems & Smart Release

About the role

AstraZeneca is looking for a Director, Head of Quality Management Systems & Smart Release for the Rare Disease Unit (RDU), based in Dublin, Athlone or Cork, Ireland. The role gives Operations one global Quality system and, through Smart Release, a path towards risk-based, AI-supported review by exception. It owns the global QMS, Complaints and Training governance and is the business owner of Smart Release.

Key responsibilities

• Lead Smart Release so that release moves over time towards review by exception, owning its vision, roadmap, business case and benefits within the Future Quality 2030 transformation.
• 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 and Smart Release.
• Own the global QMS for the RDU, including deviations, CAPA, change control, documentation, training, SAP Quality inputs, complaints and Quality Risk Management, and lead the Quality Management Review and Annual Product Quality Review.
• Simplify and harmonise processes across the network, set one global standard per process, and lead the Digital QMS programme.
• Advance Quality Management maturity in line with ICH Q10 and modernise Quality Risk Management in line with ICH Q9(R1).
• Redesign work so that AI takes on evidence gathering, classification and routing, and work with Quality Data, Digital & AI Assurance on independent assurance of data, systems and AI.
• Lead a global team of Quality Systems professionals and process owners, feed performance into the function-wide view, support inspection and audits, apply data-integrity requirements, and build knowledge management and leading indicators.

Required profile

• Degree in pharmacy, science, engineering or a related discipline; advanced degree preferred.
• 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.

Required skills

• Technical expertise in QMS, complaints, risk management, CAPA, change control and data integrity, end-to-end disposition and release across manufacturing, testing and external supply.
• Data and AI fluency to shape use cases and challenge AI outputs.