Marketing Company Operations Quality Senior Specialist

Do you have expertise in GMP/GDP Quality and passion for ensuring compliant, patient-centric supply and launch excellence in Pharmaceutical Operations Quality? Would you like to apply your expertise to impact the safe, reliable delivery and availability of medicines across Australia and New Zealand in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you What you’ll do You will develop, support, and drive excellence in Affiliate GMP/GDP Quality activities to maintain the local License to Operate, supporting the ANZ MCOQ Lead to ensure effective QMS implementation within the Marketing Company. Operating in the MCOQ function, you will perform full quality review of imported shipments, verify transport and storage conditions, and execute batch release to the AU/NZ markets—applying zero‑compromise standards for high‑criticality products where rejection prevention is essential. QMS processes oversight and execution: Lead change management, deviation management, risk management, training management, and continuous improvement. Market change implementation: Ensure changes affecting AU/NZ products (e.g., manufacturing site changes) are assessed, approved, and implemented appropriately. Product quality complaints management: Manage intake and coordinate with Medical Information under MCOQ oversight to ensure timely triage, investigation, and closure. Compliance assurance under One AZ QMS: Support delivery of one set of GMP/GDP standards and processes, harmonised with common GxP across the Affiliate. Quality Management Reviews: Support the MCOQ ANZ Lead with preparation, execution, and escalations; identify trends, risks, and mitigation actions. Cross-functional collaboration: Work closely with Marketing Company business functions to align quality with business needs, enabling launches, lifecycle changes, and supply continuity. Policy and Quality Manual stewardship: Support development, deployment, and monitoring of GMP/GDP policies and standards; keep the local Quality Manual aligned with global requirements. Essential for the role Demonstrated understanding and hands‑on delivery of a Quality Management System (QMS) in a pharmaceutical environment. Practical experience with GMP and working within a regulated quality environment. Degree level or equivalent in Life Sciences, Pharmacy, Engineering, or related field. Proven experience in Good Manufacturing Practice and a Quality function. Track record of delivering and sustaining QMS processes (e.g., change control, deviations, CAPA, training). Strong written and verbal communication with the ability to influence cross‑functional stakeholders. Experience planning and delivering projects; ability to lead, coordinate, or coach team members. Desirable for the role Understanding of multiple aspects of physical plant, technical equipment, and facilities management elements. ABOUT ASTRAZENECA AstraZeneca is a global, science‑led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas – Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory & Immunology (R&I); and Rare Disease. At AstraZeneca Australia, we have been working to deliver the best value to patients for more than 60 years, and we push the boundaries of science to deliver life‑changing medicines. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. So, what’s next Ready to apply? Submit your application now. Due to our annual Christmas shutdown and with the recruitment team on leave from Monday, 21 December to Sunday, 4 January, there may be a delay in processing applications. We appreciate your patience and look forward to reviewing your application when the team returns on 5 January 2026. Where can I find out more? Follow AstraZeneca on LinkedInVisit our website: Date Posted 04-Dec-2025 Closing Date 21-Dec-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry‑leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non‑discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr