Associate Director Clinical Quality; Cell Therapy

Do you have expertise in clinical trial quality, and a passion for Cell Therapy? Are you ready to play a pivotal role in crafting frontline quality management for clinical studies in a fast paced and innovative area? Join a company that follows the science and turns ideas into life-changing medicines - AstraZeneca might be the one for you!

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.

Within Oncology R&D, AstraZeneca is investing in our internal capabilities to help us realise our ambition to become leaders in the delivery of next-generation cellular therapies. Leveraging historical expertise in biologics engineering, gene editing and immunology across solid and haematological malignancies, we are uniquely positioned to develop cutting‑edge technologies to advance cell therapies in cancer treatment.

We are recruiting for Site Monitoring and Management (SMM) and adjacent teams based in Australia to support our clinical trials as we work towards the next generation of cell therapies.

As an Associate Director, Clinical Quality based in Sydney, you will join the Cell Therapy Clinical Operations (CTCO) Business Processes, Quality & Learning (BPQL) team, as part of the first‑line quality pillar. Reporting to the Senior Director Cell Therapy BPQL, you will lead regional quality oversight activities for SMM, embedding GCP‑aligned practices, driving training compliance and helping to develop quality metrics that surface risks early.

You will partner closely with SMM leadership, process owners and learning leads to provide expert quality advice and coaching, ensuring operational teams maintain high quality standards and are inspection‑ready.

Key responsibilities:

• First‑line quality oversight
  : provide direction and advice to Cell Therapy SMM teams on applying ICH‑GCP, AZ standards and SOPs; support country leadership to plan and implement quality control activities.

• Quality metrics: develop, track and analyse quality metrics at regional/country level; identify trends and provide actionable insights to improve investigative performance and proactive issue management.

• Quality events and CAPA management: support investigations and, where applicable, approve quality events and CAPAs in Veeva Quality Vault.

• Training compliance and enablement: assess training compliance; deliver onboarding and ad hoc quality/compliance trainings, and foster an engaging quality culture.

• Inspection and audit support: consult at country level during RIST, inspections and audits; act as SME for CT SMM quality processes; contribute to inspection responses and readiness playbooks.

• Risk management: facilitate country quality risk registers; identify, calibrate and track compliance risks; elevate and define/support mitigation activities with SMM leadership.

• Collaboration for improvement: participate in CT Quality Network forums; work across the BPQL “triangle” (process‑quality‑learning) to embed quality considerations into process design and training materials.

• Bachelor’s degree (or equivalent experience) in a relevant discipline

• At least 4 years of relevant operational and/or quality experience in drug development within a pharmaceutical, biotech or clinical research environment

• Strong knowledge of ICH‑GCP and major regulatory frameworks (FDA/EMA)

• Hands‑on experience with quality events/CAPA management and related systems (e.g., Veeva Quality Vault)

• Ability to develop and use quality metrics and analytics to drive decisions and risk mitigation

• Experience preparing for audits/inspections and contributing to inspection responses

• Demonstrated stakeholder influence, collaboration across boundaries, problem solving, and communication skills

• Ability…