Associate Director, Quality Risk Management Dublin, Leinster

Job description

Are you ready to elevate Quality Risk Management to protect patients and accelerate access to life-changing rare disease medicines? Based in Dublin, you will be a catalyst for embedding risk-based thinking across our operations, evolving our enterprise QRM process, and ensuring quality risks are understood, communicated, and acted upon with vitality. Your work will help leaders make confident decisions that safeguard product quality and supply continuity for the patients who count on us. You will partner closely with Operations (GMP/GDP) in Ireland and collaborate with global colleagues to drive consistency in risk management practices. From complex strategic ventures like due diligence and asset integrations to inspection readiness and digital risk tooling, you will bring clarity, structure, and foresight to high-stakes decisions. Can you turn complex risk signals into clear, conclusive action for cross-functional leaders? Accountabilities: - Customer Engagement and Adoption: Partner with Operations (GMP/GDP) business units in Ireland to standardize risk practices and embed risk-based thinking across sites. - Systemic Gap Identification: Identify potential systemic gaps and develop remediation plans for global and cross-functional implementation. - Stakeholder Communication: Present, explain, and defend risk metrics and procedures at Operations Quality Management Review and other key customer forums. - Program Representation: Represent the Risk Management program to GxP partners; facilitate Risk Councils, local workshops, and risk evaluation discussions. - Compliance Leadership: Ensure compliant QRM processes aligned with ICH Q9 and relevant ISO guidelines, covering risk assessment, control, communication, and review. - Methodology Excellence: Drive effective application of methodologies and tools including FMEA, FMECA, FTA, HACCP, HAZOP, PHA, ranking and filtering, and statistical methods. - SOP and Tool Evolution: Support the Business Process Owner in revising the QRM SOP and evolving risk management tools as business needs change. - Inspection Readiness: Represent QRM during health authority inspections, lead response preparation, and coordinate remediation on QRM topics. - Analytics and Reporting: Analyze risk assessments and rankings; develop risk analytics and dashboards to support Management Reviews and inform decision-making. - Risk Register Stewardship: Maintain Operations risks within the Global Quality Risk Register, ensuring traceability and prioritization. - Strategic Ventures Support: Apply proactive risk management to due diligence assessments, asset integrations, and other complex initiatives led by quality-focused strategic ventures. - Digital Enablement: Support deployment of electronic risk tools in alignment with global strategy and drive adoption across functions. Essential Skills/Experience: - Bachelor’s degree in business management, engineering, or a scientific rigor. - 6+ years of experience in a GxP Quality role supporting compliance with GMP and/or GDP regulations. - 3+ years of experience working in a GxP regulated area outside of Quality, including laboratory settings, operations/manufacturing, research and development in preclinical or clinical studies, or distribution/supply chain. - Experience with facilitating quality risk assessments under ICH Q9 and/or ISO guidelines. - Proficiency in developing presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact. - Demonstrated ability to prioritize workloads through effective decision making. - Ability to work collaboratively, raise issues in a productive way, and reach consensus in cross-functional settings, in remote work settings, across global cultures. Desirable Skills/Experience: - Advanced degree (Ph.D., MBA, or Masters). - Deep experience applying risk methodologies and tools such as FMEA, FMECA, FTA, HACCP, HAZOP, PHA, ranking and filtering, and statistical methods. -Experience representing QRM topics during health authority inspections. - Experience building risk analytics and dashboards and maintaining a global quality risk register. - Experience deploying electronic risk tools and driving cross-functional adoption. - Experience supporting due diligence assessments, asset integrations, and complex cross-functional initiatives. - Experience presenting at Operations Quality Management Review or equivalent senior forums. 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, ambition is matched by purpose. You will join a community that blends the pace and ingenuity of a biotech with the reach and resources of a global biopharma, bringing unexpected teams together to solve complex problems for people living with rare diseases. We stay close to patients and to each other, using cutting-edge science, modern digital tools, and collaborative ways of working to turn insights into action. We value kindness alongside ambition, offer tailored development to sharpen your craft, and empower you to lead change that directly improves lives. Date Posted 21-Oct-2026 Closing Date 03-Nov-2026 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