Lead QA Disposition Specialist, Cell Therapy

Quality AssuranceDispositionSeniorSpecialist, Cell Therapy Are you ready to foster an attitude of excellence? Join AstraZeneca's Global Quality Operations teamas a Quality AssuranceDispositionSeniorSpecialist, Cell Therapy at the Rockville Manufacturing Center (RMC) facility, the newest addition to our global supply network.We aim to make a direct impact on patients by delivering life-saving cell therapies.This is your chance to break newgroundand leave a collective legacy! We are investing in internal capabilities across our R&D and manufacturing organizations to help us realize our ambition to discover and deliver next-generation cellular therapies. Why Join Quality? In Quality, our work is important and valued. An unrivalled forward-looking mindset,there’sno better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products. As the voice of the patient, every batch wework onis a personal stamp of approval. Not something we takelightly,we are always innovating, trailing the latest models and technologies to improve reliability and excellence in our processes. A place to take Quality seriously – we draw learnings from others, to develop and understand what it takes to drive our modern mindset forward. Hereyou’llfeel empowered to step up, follow the science and evidence to make decisions that put patients first.If you have the passion and the drive to accelerate growth and make people’s lives better – then this is the place for you. Whatyou’lldo: As aQADispositionSenior Specialist, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The individual assures the quality and compliance for commercial and clinical products manufactured at the facility. Responsibilities: Reads, understands, and follows SOP’s andcomplies withcGMP Writes and/or revisesQuality documentationutilizingelectronic document management systems Supports the evaluation and disposition of finisheddrugproducts throughtimelyevaluation of batch records, laboratoryresultsand other cGMP documents Reviews and/or approves executed batch records, equipment logs, etc. Supportsand guidesother more junior quality assurance staffon complex situations Supports internal audits of manufacturing, analytical testing, labeling, etc. to ensure compliance with SOPs and regulatory requirements per the requirements of the self-inspection program Supports continuous improvement efforts Participates in cross-functional Tier meetings Ability to work 'off-hours' as needed to support release ofproductto meet patient dosing needs Creates and manages deviations, change controls, and CAPA recordspertaining totheir functional areas in the Electronic Quality System Assistswith deviation investigation and root cause analysis QADispoSeniorSpecialistRequired Education and Experience: 10+ years applicablequality experiencewith B.S. degree in Science, Engineering, or related technical field 15+ years applicable with High School Diploma Experience writing and investigating quality records Proven ability to work in a fast-paced environment across multiple technical functions Strong knowledge ofcGMPs Demonstrated ability to make decisions under pressure that balance patient safety,complianceand supply Preferred Experience: M.S degree in Science,Engineeringor related technical field Autologous cell therapy manufacturing or quality experience Working knowledge of international Cell TherapyGxPregulatory frameworks,regulationsand guidance Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This meanswe’reopening new ways to work, groundbreakingcutting edgemethodsand bringing unexpected teams together.Interested? Come and join our journey. Are you alreadyimagining yourselfjoining our team? Good, because wecan’twait to hear from you. Next Steps – Apply today! To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feelwell qualifiedfor this opportunity. If you know someone who would be a great fit, please share thispostingwith them. Find out more onSocial Media: LinkedIn Facebook Instagram About Operations The annual base pay (or hourly rate of compensation) for this position ranges from $100,880 to $151,321. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility toparticipatein our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coveragein accordance withthe terms and conditions of the applicable plans.Additionaldetails of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 22-May-2026 Closing Date 11-Jun-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr AstraZeneca GmbH