Associate Director Clinical Quality (Cell Therapy) at AstraZeneca

South Turramurra, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

06 May, 26

Salary

0.0

Posted On

05 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Quality, Cell Therapy, GCP-Aligned Practices, Quality Metrics, CAPA Management, Inspection Readiness, Risk Management, Stakeholder Influence, ICH-GCP, Regulatory Frameworks, Veeva Quality Vault, Process Improvement, Study Management, Site Monitoring and Management, Quality Oversight

Industry

Pharmaceutical Manufacturing

Description

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! 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. 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. What you’ll do 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; escalate 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. Essential for the role 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 to manage multiple priorities, operate regionally, and maintain accountability and ownership Desirable for the role Good understanding and knowledge regarding Cell Therapy-relevant procedures eg experience with related therapeutic areas (haematology/multiple myeloma, transplant, or autoimmune disease such as MS, scleroderma, myositis, rheumatoid arthritis) Experience with process improvement methodologies (e.g., Lean Six Sigma) and/or business process design and management Broader understanding of Study Management disciplines and cross-functional clinical operations Experience supporting SMM or quality activities across multiple countries/regions 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? Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Visit our website: www.astrazeneca.com.au and our cell therapy careers page: https://careers.astrazeneca.com/cell-therapy 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 05-Feb-2026 Closing Date 01-Mar-2026 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Associate Director will lead regional quality oversight activities for Site Monitoring and Management (SMM) teams, ensuring adherence to GCP-aligned practices, driving training compliance, and developing quality metrics to surface risks early. This role involves partnering with leadership to provide expert quality advice, coaching operational teams to maintain high standards, and ensuring inspection readiness.