Senior Specialist Quality Assurance (Compliance Team)

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, logistics and response for internal GQA, external customer and Health Authority inspections; compile evidence packs and lead follow‑up actions.
• Deliver continuous improvement by completing site quality initiatives; partner with Lean/CI to uplift investigation quality and problem‑solving tools; implement relevant cGMP updates and streamline processes to reduce complexity.
• Engage collaborators across Product Quality, QC/Microbiology, Validation, Supply Chain, Engineering and regional/global PQS networks to align to global standards and tools, taking end‑to‑end ownership to resolve compliance issues.

Essential for the role

• GMP QA/PQS experience in a pharmaceutical/technical environment (minimum 3 years), with hands‑on ownership or approval in core systems (e.g., deviations/CAPA, change control, risk, complaints, self‑inspection, supplier management, PQRs, document control, management review).
• System ownership capability including SOP authorship, user training, critical metric management, trending and effective CAPA delivery within a PIC/S Guide to GMP framework; strong grasp of a complete Pharmaceutical Quality System.
• Project and priority management skills with the ability to work independently, multi‑task and deliver to deadlines in a variable workload environment.
• Stakeholder influence and communication: confident engaging cross‑functional teams and leadership (including SLT) and operating in site‑to‑global forums; strong analytical, written and verbal communication.
• Digital literacy: proficient with MS applications (Word, Excel, etc.) and comfortable with computerised quality management systems.

Desirable for the role

• Experience across multiple areas of quality assurance within a pharmaceutical manufacturing environment, including hosting/response for inspections and external audits.
• Familiarity with computerised management systems and critical metric/governance design.
• Proven uplift in system performance (e.g., on‑time closure, investigation effectiveness, complaint/recall risk reduction).
• Background in sterile pharmaceuticals, biotechnology or similarly regulated GMP settings; prior responsibility for supplier management or QA agreements (QAAs).

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!

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

Where can I find out more?

Visit our Global Website - https://www.astrazeneca.com/

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow us on Instagram – https://www.instragram.com/astrazeneca/

AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Gold Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page – www.astrazeneca.com.au/careers.html to learn more about our commitment to fostering a flexible, diverse, and inclusive environment. We recognise that any recruitment process may present challenges, if there is anything we can do to make our recruitment process more accessible for you, please let us know via this Form.

Date Posted

Closing Date

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.