Clinical Quality Associate Director Macquarie Park, New South Wales, Australia

**Location** Macquarie Park, New South Wales, Australia

**Job ID** R-233278

**Date posted** 20/08/2025

**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.

**_ What you’ll do _**
- Support the implementation of the Late Development Oncology (LDO) Clinical Operations Quality Framework and serve as the primary contact for quality and compliance across SMM Oncology country teams, ensuring excellence in clinical trial delivery.
- Drive country-level quality planning and execution for the Oncology Portfolio in collaboration with other AstraZeneca compliance-supporting functions
- Ensure adherence to GCP and internal clinical operations standards, maintaining local procedures and guidelines.
- Lead all aspects of training compliance, deliver onboarding and ad hoc quality training, and communicate global process updates.
- Support resolution of compliance issues and investigations, including CAPA approvals and quality event management in Veeva Quality Vault, while promoting standard process sharing across SMM Oncology teams.
- Champion a strong quality culture, contribute to audits and inspections, and serve as SME for SMM quality processes.
- Analyse and interpret local quality metrics to drive performance and proactive issue management.
- Collaborate with country leadership as a member of the local country SMM leadership team to handle quality reviews, risk registers, and mitigation plans.

**Essential for the role**
- In-depth knowledge and broad experience within the pharmaceutical (biopharma) industry in a GxP regulated environment. Understanding of the drug development process and related GXP activities
- Excellent understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management.
- Excellent knowledge of international regulations and guidelines. Excellent interpersonal skills with a proven track record to effectively network cross functionally and globally.
- Critical thinking, influencing and strong risk-based decision-making skills.
- Ability to collaborate, network and interact widely and effectively at all levels.

**Desirable for the role**
- Good analytical, problem solving, negotiation and conflict resolution skills. Ability to multi-task.
- Proven ability to set and handle priorities, performance targets and project initiatives in a global environment.
- Ability to collaborate proactively, deal with ambiguity, ability to build strong customer relationships and strategic working partnerships to operate across multiple domains enabling process and system harmonization and standardization.

**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? 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.

**Where can I find out more?**
- 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._

**Date Posted**

21-Aug-2025
**Closing Date**

19-Sept-2025