Senior Specialist, Quality Assurance (Compliance) – Fixed-Term Contract (6 months, Sydney)

Do you have expertise in GMP Quality Assurance and a passion for elevating Pharmaceutical Quality Systems? Would you like to apply your expertise to strengthen inspection readiness and drive continuous improvement in a company that follows the science and turns ideas into life‑changing medicines? Then AstraZeneca might be the one for you.

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.

Business Area – Quality (Site Quality, Compliance)

Within Site Quality, our Quality Compliance team safeguards product quality and patient safety through a robust, PIC/S‑aligned Pharmaceutical Quality System (PQS). We partner across Production, Product Quality, QC/Microbiology, Supply and Lean/CI to embed guideline, ensure inspection readiness and drive data‑led improvement. You will join a collaborative team that values autonomy, practical problem solving and digital curiosity, with clear accountability and strong support through workload spikes and inspection cycles.

What you’ll do

- Own and operate PQS subsystems, leading defined elements such as deviations/investigations and CAPA, change control, quality risk management, complaints, self‑inspection, external audits, supplier management, Product Quality Reviews (PQRs), document control, site management review, quality metrics reporting, and regulatory compliance activities.

- Act as the site‑level system guide by holding/authoring SOPs, providing end‑user training and coaching, handling record flow and on‑time closure, and ensuring master data alignment to Health Authority filings and quality requirements.

- Lead governance and performance by running critical metrics, trending and governance cadence; present signals, risks and remediation to partners including the Site Leadership Team (SLT); ensure commitment tracking and effective closure.

- Drive inspection readiness by planning and leading preparation,