QA Manager, Warehouse - Alexion

QA Manager, Warehouse ADMF Reports to: Director of Quality, BDS Location: Dublin Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. As a leader in rare diseases for more than 30 years, Alexion is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Position Summary The QA Manager is responsible for overseeing and assuring the quality of all activities related to the warehouse that supports the ADMF site, operating under EU GDP (Good Distribution Practice) and relevant GMP (Good Manufacturing Practice). The position will be responsible for providing quality oversight for the receipt, storage, picking and dispensing of materials within the warehouse as well as the shipping of materials and finished products from the ADMF Warehouse. The candidate will embody the AstraZeneca, Alexion Rare Disease Unit values to “put Patients First,” “Follow the Science,” “play to Win,” and “Do the Right Thing.” To be considered candidates must have strong experience in GxP, quality systems, and Pharmacovigilance. The ideal candidate will have the ability to function independently, assess risk, and evaluate competing priorities in a matrix environment. Successful candidates are flexible, able to operate amid ambiguity, have a natural curiosity to learn, and are eager to take ownership of the role. Principal Responsibilities Maintain, and continuously improve the warehouse Quality Management System (QMS) aligned with EU GDP (EudraLex Volume 4, GDP Guidelines 2013/C 343/01) and GMP, including procedures, records, quality metrics, and management review. Ensure adherence of warehouse personnel to warehouse operations procedures and work instructions. Identify opportunities for improvement and drive continuous improvement initiatives across the warehouse areas. Approve SOPs, work instructions, and forms related to warehouse activities. Conduct regular audits / walkthroughs, including GDP, GMP and safety, environmental monitoring, pest control verification, and housekeeping inspections. Act as the quality lead on change controls for the warehouse, equipment, systems, and processes; perform quality risk management (QRM) per ICH Q9 principles for changes, deviations, and continuous improvement. Ensure timely deviation reporting, root cause analysis, and CAPA effectiveness verification for issues like temperature excursions, picking errors, packaging damage, and transport incidents. Monitor, investigate, and trend deviations or non-conformances; drive corrective actions and improvements. Oversee qualification of critical equipment and systems (e.g., temperature-controlled stores, fridges/freezers, data loggers, WMS), transport route validation/qualification, and mapping for temperature-controlled areas. Ensure GDP-compliant receipt, storage, and dispatch processes, including segregation of quarantined, recalled, returned, or rejected goods; FEFO practices; tamper-evident controls; and prevention of falsified medicines entry. Recall, Returns, and Complaints Management: Maintain tested recall procedures and traceability, manage returns assessment and disposition (including falsified/suspect product handling), and investigate applicable quality complaints, communicating with the Responsible Person (RP) and relevant authorities as required. Oversee warehouse inspection readiness activities, act as the quality representative during regulatory health authority inspections, and track follow-up actions stemming from inspection observations. Additional Responsibilities Represent Quality and build positive relationships as an effective partner that provides value to and demonstrates the value of Quality to the business. Focus on the management of authorized activities and the accuracy and quality of records Ensure initial and continuous training programs are implemented and maintained Ensure that root cause analysis is conducted for all audit findings and that CAPA are developed and implemented in a timely manner Keep appropriate records of any delegated duties. Support other initiatives as delegated. Qualifications and Role Requirements Bachelor’s degree in physical /life science or pharmacy, or other relevant degree with applicable industry experience. 3-5 years of hands-on Quality Assurance / Compliance and management experience in warehouse pharmaceutical/ biotech industry. Knowledge in a broad range of pharmaceutical activities and Quality Systems. Experience in a Lean/6-Sigma manufacturing or warehouse environment is an advantage. Strong verbal and written communication skills; ability to present information clearly and concisely Knowledge of industry business platforms including: Veeva Vault, SAP, MS Office systems and other custom programs; generally advanced computer skills Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs Ability to multi-task and prioritize work while operating autonomously with potential ambiguity Strong leadership and organizational ability. Date Posted 08-Apr-2026 Closing Date 21-Apr-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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.