The Role:

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is strengthening Australia's biotech landscape through a long term partnership focused on pandemic resilience. Our Melbourne based mRNA vaccine manufacturing facility will support rapid response to future health threats while creating skilled jobs and developing local talent. We welcome professionals ready to help advance global health security.

This is a senior Quality leadership opportunity at the heart of Moderna's Manufacturing and Supply operations in Australia, with responsibility for end-to-end Quality Assurance across Drug Substance (DS) and Drug Product (DP) sterile manufacturing and Country Quality. As the senior-most Quality leader in Australia and Site Quality Head, you will shape and execute a multi-year Quality strategy, safeguard product quality and patient safety, and ensure a sustained state of GxP compliance and inspection readiness against TGA requirements, PIC/S Annex 1 and Moderna global standards.

Leading the Clayton Quality Assurance organization, you will be the primary Quality business partner to the Site Head and Country General Manager and a strategic interface between Australian requirements, business goals and Moderna's global Quality strategy. Your influence will extend across APAC, contributing to regional Quality strategy, new-market and site readiness, Quality risk management, current capabilities, evolving supply models and future network expansion.

This role combines enterprise-level Quality strategy with hands-on operational leadership. You will have the authority and independent judgment to elevate, pause or stop GxP activities when product quality,



patient safety or regulatory compliance may be impacted, while building a high-performing Quality organization equipped for Australia's current operations and future APAC growth. You will also have opportunities to get close to generative AI and emerging digital tools, exploring how they can strengthen Quality insights, organisational learning, risk identification and the effectiveness of Quality operations within appropriate GxP frameworks.

Here’s What You’ll Do:

Serve as the senior-most Quality leader in Australia, with overall accountability for the Quality strategy, compliance state and Quality performance of Australia Manufacturing and Supply, including site-level GxP compliance, inspection readiness and performance of the Quality Management System (QMS).

Provide strategic leadership to the Clayton Quality Assurance organization supporting Drug Substance and Drug Product sterile manufacturing operations, building a strong Quality culture while maintaining a consistent QA presence on the manufacturing floor and at CMOs.

Develop and execute a multi-year Quality strategy for Australia Manufacturing and Supply aligned with site, country, APAC and Global Quality priorities.

Contribute to and help shape APAC Quality strategy, including the Quality operating model, regional risks, future capabilities and expansion priorities.

Lead Quality readiness for new markets, sites, capabilities and supply models within Australia and, as appropriate,



across APAC, ensuring Quality and regulatory requirements are incorporated early into business and network planning.

Provide Quality leadership and risk assessment for regional growth and expansion, identifying emerging compliance, regulatory, supply and product-quality risks and ensuring appropriate mitigation and escalation.

Serve as the primary Moderna Quality representative to relevant GxP government agencies, including the Therapeutic Goods Administration (TGA), leading responses to TGA and other health authority inspections, interactions and communications.

Oversee the Authorized Person and Country Quality Representative responsible for market release, ensuring robust systems and compliance with TGA requirements.

Act as the senior Quality decision-maker for Australia Manufacturing and Supply, with authority to elevate, pause or stop GxP activities where product quality, patient safety or regulatory compliance may be adversely impacted.

Exercise independent Quality judgment and senior-level decision rights on significant compliance, product quality, inspection and business-continuity matters, escalating to Global Quality leadership where appropriate.

Ensure compliance with sterile manufacturing expectations, including PIC/S Annex 1 and contamination control strategies.

Ensure implementation and ongoing performance of robust Quality Systems, including Deviation Management, CAPA, Change Control, Training and Documentation.

Represent Quality on the Site Leadership Team, the Australia commercial leadership team and in strategic country-level discussions, ensuring Quality considerations and risks inform key business, investment, network and expansion decisions.

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📌 Site Quality Head (Moe)
🏢 Moderna
📍 Moe