Head of Quality Management Systems & Smart Release Dublin, Leinster

Job description

Makes Quality simpler and release faster by giving Operations one global Quality system and, through Smart Release, a path towards risk-based, AI-supported review by exception over time. The role owns the global Quality Management System (QMS), Complaints and Training governance within the Rare Disease Unit (RDU), setting one global standard for each process so that every team and site works the same way and learns from the same evidence. It is the business owner of Smart Release, accountable for its vision, roadmap, adoption and benefits. Locations - Dublin, Athlone or Cork, Ireland Key accountabilities Lead Smart Release so that release moves, over time, towards review by exception • Own the Smart Release vision, target process, roadmap, business case and benefits, as part of the integrated Future Quality 2030 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. Each team leader stays accountable for compliant execution in their own area. • 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. Give Quality Operations one simple global QMS • Own the global QMS for the Rare Disease Unit and its core processes: deviations and quality events, corrective and preventive action (CAPA), change control, documentation, training, SAP Quality inputs, complaints and Quality Risk Management; lead Quality Management Review, lead Annual Product Quality Review (APQR), which each site carries out against global requirements. • Set one global standard for each process, with clear process owners, local responsibilities and escalation routes; simplify and harmonise processes across the network, and lead the Digital QMS programme so Quality workflows become simpler and digital for every team. • Advance Quality Management Maturity in line with ICH Q10, and modernise Quality Risk Management in line with ICH Q9(R1) so that risk, evidence and decisions are clearly linked. • Build knowledge management and leading indicators so that lessons are captured, reused and acted on earlier. AI compliance in QMS • Redesign work so that, over time, AI takes on evidence gathering, classification and routing, and experts spend their time on judgement. • Work with Quality Data, Digital & AI Assurance, which independently assures data, systems and AI for their intended use. Lead a capable, inspection-ready global team • Feed Quality system and release performance into the function-wide view of performance. • Lead inspection and audit support for QMS and Smart Release; escalate systemic Quality risks and drive timely, effective closure of commitments. • Apply data-integrity requirements to the data QMS, Complaints and release processes create. • Lead and develop a global team of Quality Systems professionals and process owners, with strong succession, new skills for AI-enabled work and a culture of continuous improvement. You will need to have: 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 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 Enough data and AI fluency to shape use cases and challenge AI outputs Date Posted 20-Oct-2026 Closing Date Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. Apply Apply EXPLORE THE LOCAL AREA Take a look at the map to see what's nearby. Similar Roles Recently Viewed Similar Roles View All of Our Available Opportunities You have no saved jobs. Join our Talent Network Be the first to receive job updates and news from Alexion Sign up to be the first to receive job updates. --> Sign up INCLUSION & DIVERSITY We understand that creating a purpose-driven, rewarding culture is critical to our collective success and our mission to serve the rare disease community. Learn more INCLUSION & DIVERSITY ABOUT US To transform the lives of people affected by rare diseases and devastating conditions by continuously innovating and creating meaningful value in all that we do. Learn more ABOUT US EARLY TALENT Our science wouldn’t be possible without our team of passionate, driven and dedicated individuals who make up Alexion. Start your career with us now! Learn more EARLY TALENT