Associate Director, Quality - Australia & New Zealand

Do you have expertise in GxP Quality leadership and a passion for ensuring safe, timely patient access to medicines across Australia and New Zealand? Would you like to apply your expertise to impact inspection readiness, GDP/GMP excellence, and Quality decision‑making in a company that follows the science and turns ideas into life‑changing medicines? Then Alexion/AstraZeneca might be the one for you!

ABOUT ALEXION

Alexion/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 Alexion/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.

As the dedicated rare disease business within AstraZeneca, Alexion focuses on serving patients and families affected by rare conditions. The ANZ Quality function partners closely with Commercial, Supply Management, and Regulatory & Quality Affairs to embed robust GDP/GMP practices, uphold inspection readiness, and ensure continuous product availability so patients receive medicines safely and on time.

What you’ll do

Lead GxP quality for Australia and New Zealand, owning the Quality Management System and acting as the go‑to for GDP/GMP, inspection readiness, and quality decision‑making in a purpose‑led rare disease business.

• Oversee alignment of global and local quality standards and policies with ANZ GxP guidelines, ensuring robust GDP/GMP practices across Commercial and Supply.
• Lead deviation and complaint management, supplier quality oversight, product quality reviews, and change control; drive effective, risk‑based CAPA.
• Embed ALCOA+ and digital QA tools; develop KPI dashboards and performance trend analyses to proactively identify and address excursions.
• Coordinate internal/external audits and inspections; maintain SOPs, validations/qualifications, periodic reviews, and regulatory documentation.
• Lead quality risk assessments and benchmarking to adopt efficient, innovative practices and implement improvement initiatives.
• Represent Quality for ANZ, partnering with Supply Management to assure continuous product availability and providing quality input to projects and NPIs.

Essential for the role

• University degree in Science or a related discipline.
• 7+ years’ experience managing a compliant QMS and QA documentation in regulated pharma/biotech.
• Deep knowledge of change control, deviation and complaint management, supplier oversight, CAPA and continuous improvement.
• Proficiency with QA digital tools and documentation systems; experience delivering KPIs/reporting with performance trend analysis.
• Strategic, decisive, results‑focused and adaptable leader with strong communication, collaboration, influence, and customer/patient focus.
• Proven track record supporting inspection readiness.

Desirable for the role

• Cross‑functional leadership experience.
• Exposure to NPIs/launches and quality input to projects.
• Experience chairing governance forums (e.g., Tier 3 Regulatory & Quality Affairs) and contributing to Quality & Compliance meetings and disease area forums.
• Experience planning and delivering quality training, technical mentorship, and guiding teams on regulatory expectations and digital QA applications.

Why Alexion/AstraZeneca?

At Alexion/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!

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.