External QA Manager, External Quality Operations Dublin, Leinster

Job description

External QA Manager, External Quality Operations Location: Dublin, Ireland Job reference: R-262356 Date posted: 10/21/2026 This is what you will do: The QA Manager for external quality operations supports the QA activities as required by Alexion External Quality in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. Intern for external quality performs’ all responsibilities in accordance with company policies, procedures, and regulations. You will be responsible for: Quality Overight of Contract Manufacturing Organisations (CMOs) manufacturing Drug product on Alexions behalf. Authoring, review and approval of QA-related procedures. Review of batch documentation. Tracking of quality management system activities including deviations, CAPAs and change controls. Perform all job functions in compliance with cGMPs and maintain accurate and legible records. Where required, maintain external quality metrics/key performance indicators ensuring site visibility and trending to support continuous improvement activities. Documentation review of SOPs, master batch records, policies, standards, validation protocols and reports as required. Other activities, as required to support the Alexion External Quality team and stakeholders. You will need to have: This position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary. The person in this position will receive supervisory direction on all routine and non-routine activities. Routine activities will be unsupervised as training and competency develops. The person in this position must have good organizational skills and the ability to lead projects/ engage with cross functional stakeholders. The position requires the individual to work collaboratively with colleagues, peers and managers. A good understanding of the concepts and systems applied to cGMP operations is expected. Proficient in the use of approved AI technologies to support analysis, risk assessment, and operational efficiency. Able to critically review AI-generated outputs, maintain data integrity, and ensure compliance with GxP and regulatory expectations. We would prefer for you to have: B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry , Microbiology or Pharmacy +5 years Quality experience, preferably experience working with CMO’s. 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