Brief Job Profile Description This role will be responsible to guide and support the execution and continuous improvement of site Quality Systems and Compliance activities. The individual will serve as a key point of contact for deviation and CAPA management, change control governance, Quality Management Review preparation, and Annual Product Quality Reviews for an autologous cell therapy manufacturing site with products in clinical development and commercial manufacturing. This person will be responsible to execute site self-inspections and coordinate inspection readiness activities for regulatory inspections, corporate audits, partner audits by ensuring the compliant execution of established procedures including (but not limited to) timely management of audit commitments and responses. Quality data analysis metrics development (and report execution), and participation in cross-functional governance forums will be required to ensure compliance with GxP requirements and regulatory expectations. Accountabilities • Support the effective execution and continuous improvement of site quality systems in alignment with AstraZeneca Cell Therapy procedures and applicable regulatory requirements. • Prepare for, facilitate, and communicate the outcomes of the routine site Quality System governance meetings (including, but not limited to, Deviation Review Board, Change Control Review Board, and Quality Management Review meetings). • Support Quality Management Review preparation by coordinating inputs and assisting with the development of metrics, slides, and presentation materials. Connect cross-functional meeting outcomes to defined actions, generate meeting minutes, and track progress of quality actions. • Plan, lead, and document site self-inspections as a lead auditor, including defining scope, coordinating audit activities, evaluating objective evidence, preparing reports, and tracking corrective actions through closure. • Guide the preparation, review, and timely completion of Annual Product Quality Reviews, including coordinating cross-functional inputs. • Support site inspection readiness initiatives, including facility walkthroughs, readiness assessments, inspection preparation, front-room and back-room support, and tracking observations, commitments, and responses through closure. • Provide expert guidance on site compliance with global regulations, international standards, and industry best practices for quality management systems, including, but not limited to, ICH Q8, Q9, Q10, and Q12; 21 CFR Parts 11, 210–211, and 600–610; EudraLex Volume 4; EU Annex 1; PIC/S Annex 2A; and applicable FDA and EMA guidance for cell therapy. • Analyze quality-system data and develop clear reports, dashboards, and insights on metrics, trends, risks, and key performance indicators using applicable digital tools. • Participate in cross-functional Tier meetings. • Create and manage deviations, change controls, and CAPA records pertaining to functional areas in the Electronic Quality System. Assist with and conduct deviation investigations and root cause analysis. • Liaise with AstraZeneca global stakeholders across multiple time zones for alignment on best practices and harmonization within the Quality Management System. • Flexibility to work outside standard business hours, as needed, to support time-sensitive product release activities and patient dosing schedules. • Completes additional assigned duties, as needed, to support site, quality, compliance, and business objectives, consistent with the scope and level of the position. Qualifications and Skills Essential Skills/Experience: 7+ years applicable quality experience with bachelor’s degree in science, engineering, or related technical field. Experience writing and investigating quality records. Proven track record to work in a fast-paced environment across multiple technical functions Strong knowledge of cGMPs and ability to interpret regulatory requirements and provide practical compliance guidance to cross-functional teams. Experience leading or supporting GxP audits or self-inspections, as well as supporting/hosting health authority inspections. Demonstrated ability to analyze quality data, identify trends and risks, prepare clear reports, and manage multiple priorities. Strong facilitation, written communication, and stakeholder-management skills. Proficiency with electronic quality systems, reporting tools, and standard Microsoft applications. Demonstrated ability to make decisions that balance patient safety, compliance and supply. Desirable Skills/Experience: Master’s degree in science, engineering or related technical field. Autologous cell therapy manufacturing or quality experience. Experience preparing or coordinating Annual Product Quality Reviews. Lead auditor training or a recognized quality auditing certification. Working knowledge of international Cell Therapy GxP regulatory frameworks, regulations and guidance. Date Posted 20-Oct-2026 Closing Date 02-Nov-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. 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.

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