The Role
Join a pioneering team revolutionizing medicine through mRNA technology. You'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
This is a pivotal individual contributor position responsible for leading country-level quality activities in Australia while serving as the designated Authorized / Responsible Person (AP / RP) under the Therapeutic Goods Administration (TGA) requirements.
The Associate Director ensures Moderna's mRNA products distributed in the Australian market fully comply with cGMP, GDP and local regulatory obligations.
You will build and continuously enhance Moderna's local Quality Management System (QMS), act as the primary liaison with local and global regulatory stakeholders and play a key role in inspection readiness.
Responsibilities:
* Serve as the designated AP / RP under TGA accountable for GMP and GDP compliance in Australia.
* Review and approve batch manufacturing testing and release documentation to ensure alignment with internal standards and local regulations before final disposition.
* Maintain oversight of deviations, non-conformances, change controls and ensure timely documentation and resolution.
* Drive implementation and continuous improvement of the local Quality Management System (QMS).
* Act as the local Quality liaison for all GxP compliance activities at the Clayton site.
* Prepare and lead Quality Management Reviews and monitor Quality KPIs.
* Coordinate audit readiness efforts and support external and internal inspections.
* Oversee interactions with third-party logistics providers for GDP-compliant product handling, storage and distribution.
* Support lifecycle oversight by contributing to relevant R&D study programmes.
* Manage complaint handling, recalls, risk assessments and medical queries in compliance with applicable frameworks.
Key Responsibilities:
* Create, revise and implement SOPs and work instructions supporting the QMS.
* Manage local execution of distribution procedures in compliance with GDP.
* Monitor pharmaceutical product stock levels including oversight of returns, batch recalls, shortage declarations and distribution authorisations.
* Foster a positive and inclusive work culture that embraces collaboration, innovation and continuous improvement.
* Rigorously apply all internal quality procedures and regulatory standards in daily operations.