Global Sterility Assurance Systems & Standards Lead
CSL
Sterility assurance oversight and support
Gxp fda eu regulatory compliance experience
Microbial contamination control strategy
This strategic leadership role executes sterility assurance oversight to ensure CSL sites and CMOs operate in compliance with the highest regulatory standards
Job Summary
This strategic leadership role executes sterility assurance oversight to ensure CSL sites and CMOs operate in compliance with the highest regulatory standards.
The position requires providing expert input on major deviation investigations related to sterile filtration, aseptic filling, lyophilization, and media fills.
CSL is a global biotherapeutics leader employing 32,000 people who deliver lifesaving therapies to more than 100 countries.
Matching Summary
This strategic leadership role executes sterility assurance oversight to ensure CSL sites and CMOs operate in compliance with the highest regulatory standards.
Skills & Requirements
Must-have
Sterility assurance oversight and support
GxP FDA EU regulatory compliance experience
Microbial contamination control strategy
Aseptic filling and sterile filtration expertise
Inspection readiness management for sites
Nice-to-have
Strategic leadership in global quality operations
Proactive risk management capabilities
Collaboration across technical and R&D functions
Continuous improvement culture development
Key Requirements
Bachelor's degree in microbiology or biology
8-10 years pharmaceutical manufacturing experience
Direct QA experience in sterility assurance context
Experience interacting with regulatory authorities