Introduction to role: Are you ready to turn rigorous quality oversight into real-world impact for people relying on life-changing medicines? Do you want to see the outcomes of your work in safe, reliable product reaching patients on time? As QA Specialist for Finished Product at our College Park site, you will safeguard the integrity of commercial and clinical packaging and labelling activities. You will connect day-to-day batch documentation and deviation management with the broader mission of uninterrupted, compliant supply for patients with rare and devastating conditions. Working closely with cross-functional partners and Qualified Persons, you will ensure our testing, packaging, storage and release processes meet our Quality Management System and all applicable regulations. Accountabilities: Batch Documentation Oversight: Issue and review batch documentation for finished product packaging, ensuring completeness, accuracy and timely progression to release for both commercial and clinical supply. Deviation and CAPA Leadership: Provide quality input, oversight and guidance to deviations and investigations to drive robust root cause analysis, effective CAPAs and on-time closure in line with QMS. QP Release Support: Prepare and review the documentation required to support QP certification and release, ensuring data integrity and clear traceability. Change and Complaint Management: Manage changes and lead actions assigned to the College Park site from the complaints process, ensuring timely resolution and learning integration. Quality Metrics and Reporting: Generate, analyze and report quality metrics to aid in risk identification, drive decisions and track progress on commitments. Document Lifecycle Management: Review and approve SOPs, Packaging Instructions, Work Instructions, technical reports and protocols to maintain current and compliant documentation. Quality Risk Management: Participate in and provide oversight of risk assessments, ensuring controls are defined, implemented and maintained throughout the product lifecycle. Document Ownership: Author, review and approve Quality Agreements to align practices, define clear roles and responsibilities, clarify expectations and enable consistent execution. Inspection Readiness and Support: Lead and support inspection readiness activities; engage confidently with health authority inspectors; coordinate responses and track follow-up to closure. Continuous Improvement: Identify improvement opportunities across packaging and related operations; influence stakeholders in a matrix environment to embed enhanced ways of working. Essential Skills/Experience: Bachelor’s degree in science, engineering or equivalent 3+ years QA experience in international pharmaceutical and/or biotech industry with packaging experience an advantage. Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization Strong verbal and written communication skills with well-structured communication and presentation ability. Desirable Skills/Experience: Experience in finished product packaging and labelling operations within a GMP environment. Prior support of QP certification and release activities. Hands-on use of electronic quality systems and eDMS (for example, TrackWise, Veeva, or equivalent). Participation in EMA, FDA or other health authority inspections and response management. Proficiency with root cause analysis tools and risk methodologies (5-Why, Fishbone, FMEA, ICH Q9). Exposure to biologics or rare disease supply chains. Lean/Six Sigma training or practical continuous improvement experience. 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. #J-18808-Ljbffr
National Account Manager - Field Based Role Location: Ireland Competitive salary and Benefits This National Account Manager role focuses on delivering sustainable business growth and better outcomes for people living with rare diseases across Ireland. The position leads the design and execution of strategic, data‑driven account plans that align with brand and business strategy, challenge existing care pathways, and influence key stakeholders to improve diagnosis, referral and appropriate therapy uptake. Working closely with a cross‑functional team, the role anticipates evolving healthcare system needs, builds innovative solutions with customers, and turns insights into practical actions that change knowledge and behaviour in a highly competitive environment. Accountabilities Specialist Account Planning & Execution Design and implement high‑impact account plans, based on a deep understanding and direct customer insights for priority accounts, that will deliver against brand and business growth objectives for specific rare disease indications. Include measurable account key performance indicators (KPIs) and regularly evaluate performance against those KPIs. Customer & Stakeholder Engagement Include customer engagement plans and activities within the account plans that tailor engagement and content delivery according to the customer segment needs and desired behavioural change objectives, leveraging data and insights to identify opportunities, address challenges, and deliver patient and customer‑centric solutions. Uses a range of face‑to‑face, peer‑to‑peer and digital channels to apply the right level of engagement. Deliver exceptional customer experience Combines deep customer insights with the value proposition of our medicines to tailor communication and content to the needs and values of the customer, proactively work to better understand the customer drivers and barriers to ensure successful diagnosis, referral and uptake of therapy (as clinically relevant) in a competitive launch environment while adhering to compliance standards, relevant policy and codes of practice. Essential Skills/Experience Demonstrable training in Ireland pharmaceutical regulations and IPHA/EFPIA Code compliance (completion and maintenance of certification). Valid licence to drive in Ireland. Good understanding of the healthcare system and access to medicines. Ability to design data‑driven account plans with clear KPIs, translate insights into targeted tactics, and iterate based on performance. Skilled in tailoring value messages to segment needs, managing complex stakeholder maps, and negotiating to agreed outcomes. Proficient in the use of digital channels to optimise customer engagement. Experience developing and executing high‑value account plans in complex, competitive, or launch environments, with measurable outcomes. Advanced analytical capability to interpret complex internal and external data (epidemiology, pathway data, prescribing/uptake, access metrics). Strong understanding of the Irish healthcare system, speciality or rare disease therapy landscape, and ethical, compliant sales practices. Proficiency with CRM systems (e.g., Veeva) and account planning tools/dashboards. Desirable Skills/Experience Degree in life sciences or a relevant discipline (e.g., biomedical sciences, pharmacy, health economics). Advanced training in account management, negotiation, or healthcare policy. Specific experience in rare disease across specialist centres or networks. Exposure to new product launches and/or account‑based marketing in specialty care. Experience collaborating with Market Access/Medical Affairs to align account tactics with access and education objectives. Ready to shape access for rare disease patients across Ireland and turn insight into real‑world impact? Apply now! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. 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. #J-18808-Ljbffr
Alexion is looking for a National Account Manager to drive sustainable growth and improve outcomes for rare disease patients in Ireland. This role leads strategic account planning and engages key stakeholders to enhance therapy uptake. Candidates should possess strong insights into the Irish healthcare system and relevant industry regulations, along with advanced skills in account planning and digital engagement. Join us to shape access for rare disease patients and make a meaningful impact. #J-18808-Ljbffr
Alexion in Dublin College Park is seeking a QA, New Product Introduction (NPI) Technical Manager to ensure quality leadership across new product introductions. The ideal candidate will have 6-8 years of experience in a cGMP Biotech environment and a strong understanding of regulatory compliance. This role is critical to delivering life-changing therapies to patients, providing QA oversight and direction while partnering with various teams. A dynamic work environment focused on professional development is offered along with a hybrid work model. #J-18808-Ljbffr
QA, New Product Introduction (NPI) Technical Manager Location: Dublin – College Park Company: Alexion, AstraZeneca Rare Disease Business Area: Operations – Quality Job Type: Full‑time | Grade C | On‑site (Hybrid – minimum 3 days onsite) Drive quality excellence as we bring new therapies to patients At Alexion, part of AstraZeneca’s Rare Disease division, quality is fundamental to everything we do. Our Dublin College Park site plays a critical role in introducing new products, technologies, facilities and processes that enable delivery of life‑changing medicines to patients worldwide. We are seeking an experienced QA, New Product Introduction (NPI) Technical Manager to provide quality leadership across new product introductions and site improvements. This role ensures that all new products, equipment, systems and processes are implemented in full alignment with cGMP, regulatory and corporate requirements , while supporting a robust and evolving Quality Management System. What you’ll do As QA, NPI Technical Manager, you will act as a key quality partner across the site, providing expert QA oversight and guidance during new product introductions and technical change initiatives. You’ll work closely with cross‑functional partners to ensure quality is embedded at every stage—from concept through commercial readiness. Your responsibilities will include: Partnering with Technical Services, Manufacturing, Engineering, Facilities, Validation, QC, Supply Chain, Packing, Warehouse, QPs and QA teams to provide QA leadership and technical direction Providing QA oversight for NPIs, new technologies, and new or modified facilities, equipment and processes across manufacturing, packing and analytical areas Ensuring compliance with EU, FDA and other regulatory requirements, corporate standards and internal procedures Leading risk‑based quality strategies and advising on appropriate control approaches Overseeing qualification and validation activities (CQV), including review and approval of protocols and reports for facilities, equipment, utilities, IT systems, analytical methods, process and cleaning validation Conducting timely, risk‑based review and approval of GMP documentation such as SOPs, batch records, sampling plans, process descriptions and project documentation Supporting quality aspects of new material introductions and ensuring material readiness for GMP use Reviewing and approving deviation investigations related to NPI activities and ensuring effective root cause analysis and CAPAs Participating in project change control programs for new or modified facilities, equipment, systems and processes Implementing and periodically reviewing QA procedures relating to NPIs, validation and associated work areas Conducting and supporting quality risk assessments and ensuring quality decisions are well documented and communicatedSupporting audit readiness and regulatory inspections (internal and external) Identifying and driving continuous quality improvement initiatives Undertaking additional QA responsibilities as required by site Quality leadership Essential experience: Third‑level qualification (e.g. B.Sc. in Science or Pharmacy) or equivalent Ideally 6–8 years’ experience in a cGMP Biotech Quality Assurance environment Strong working knowledge of cGMP requirements for bio/pharmaceutical manufacturing, packing, analytical testing and storage Experience supporting new product introductions, technical transfer and CQV activities Demonstrated ability to provide QA oversight across complex, cross‑functional projects High levels of accuracy, attention to detail and ownership Self‑motivated with strong energy and eagerness to learn Preferred experience: Experience within biopharma manufacturing and aseptic processing QA experience supporting QC, supplier quality or packing validation Strong analytical, auditing and technical writing skills Experience using multiple computerised manufacturing and QA systems Strong planning and organisational skills with the ability to track and deliver QA commitments Adaptability and comfort working in a changing, project‑driven environment Excellent interpersonal and communication skills (written and verbal) Why Alexion? At Alexion, you’ll be part of a passionate organisation dedicated to transforming the lives of people living with rare diseases. You’ll work in a highly collaborative environment, supporting high‑impact projects and playing a critical role in bringing new therapies to patients—safely, compliantly and efficiently. Dublin College Park offers a dynamic, modern manufacturing environment, strong investment in new technologies, and meaningful opportunities for professional development within the AstraZeneca family. Ready to make an impact? If you are passionate about quality, thrive in technically sophisticated environments, and want to play a key role in new product introductions that truly matter, we would love to hear from you. Apply today and help ensure every new product meets the highest standards of quality and patient safety. 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. #J-18808-Ljbffr
A global biopharmaceutical company seeks a QC Analyst for a 12-month fixed-term contract in Dublin. This role involves ensuring compliance with regulatory standards by performing hands-on testing, data reviews, and technical mentorship. Essential skills include a BSc in Chemistry, regulatory knowledge, and experience in investigation methodologies. Working in a collaborative environment, the position supports the QC management team and drives continuous improvement initiatives. #J-18808-Ljbffr
A global biopharmaceutical company in Blanchardstown is looking for a qualified individual to join their Epidemiology and Real World Science team. This role emphasizes the application of Real World Data to enhance healthcare delivery and supports various stakeholders in Clinical Development and Patient Safety. Ideal candidates must possess a Master's degree in a relevant field, have experience in data analysis, and be comfortable coding in SQL and technologies like R or Python. A collaborative spirit and problem-solving skills are essential for this office-based position. #J-18808-Ljbffr
This is what you will do: The Epidemiology and Real World Science team in Alexion–AstraZeneca’s Rare Disease Unit accelerates patient access to innovative medicines by advancing the scientific use of Real World Data (RWD). In this role, you will apply RWD to support the rare disease portfolio, aligned with AstraZeneca best practices and standards. Building on AstraZeneca’s strong Real World Evidence foundation and internal data assets, the team is expanding through a dedicated Real World Data Science capability. Successful candidates will tackle challenging problems with innovative methods to deliver Real World Insights and Evidence for stakeholders in Clinical Development, Regulatory, and Patient Safety. The ideal candidate is a curious, self‑directed learner with a proven record of deriving value from routinely collected healthcare or observational data, delivering health analytics across Public Health, Pharmaceutical R&D, Commercial/Payer, and Patient Safety. You will be responsible for: Deliver/Implement and support advanced secondary analyses of data from EMR, claims and primary observational data required by Therapeutic Area (TA) RWE strategies Comfortable working in a rapid analytics environment alongside stakeholders to ideate appropriate/impactful analysis along with implementation Provide clear technical input, options and directions to support strategic decisions made by AZ observational study teams on study design, data partner selection and guidelines in RWE data utilization Monitor work performed by contract personnel and vendors Maintain a strong insight into the capabilities of potential external partners in RWE, especially for US and emerging markets Demonstrate best practice in Real World Data Science across multiple domains, and/or stakeholder groups You will need to have: Minimum of master’s degree in Biostatistics, Epidemiology, Public Health, Statistics, Mathematics, Data Science, or related field with at least 3 years in the pharmaceutical industry, biotechnology, or consulting environment The duties of this role are generally conducted in an office environment. As is typical of an office‑based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non‑linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours We would prefer for you to have: This is a hands‑on role – so be excited to code! Enthusiastic about building on and learning new methods and ways to use real world data to change the practice of medicine Demonstrated ability to build long‑term relationships with stakeholders, understand relevant scientific/business challenges at a deep level and translate into a programme of data science activities to deliver value to the business Hands‑on experience with EMR, disease registries, and/or insurance claims databases Experience with in clinical data standards, medical terminologies and controlled vocabularies used in healthcare data and ontologies (ICD9/10/SNOMED) Experience in supporting pharmacoepidemiology studies with proven track record of advancing approaches with statistics/machine learning/data science Ability to lead and handle multi‑disciplinary data science projects Proficient in SQL Proficient in at least one of R, Python Date Posted 16-Jan-2026 Closing Date 15-Feb-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. #J-18808-Ljbffr
