Senior Specialist, On-the-Floor, Quality Assurance

Moderna · Melbourne, Australia +1 more

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What they're looking for

Senior Quality leadership experience in regulated pharmaceutical or biotech manufacturing
Deep knowledge of GxP compliance, TGA requirements, and PIC/S Annex 1 standards
Proven track record managing Quality Assurance for sterile drug substance and drug product operations
Experience leading Quality organizations and building high-performing teams
Regulatory inspection experience and government agency liaison capabilities
Strategic planning and cross-functional leadership in global manufacturing networks

What you'll be doing

Lead Quality strategy and compliance state for Australian manufacturing and supply operations
Manage Clayton Quality Assurance organization supporting sterile drug substance and product manufacturing
Develop multi-year Quality strategy aligned with site, country, APAC and global priorities
Serve as primary Moderna representative to TGA and other health authorities for inspections and communications
Exercise independent judgment to escalate, pause or stop GxP activities when quality or safety at risk

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