Global Sterility Assurance Systems & Standards Lead
CSL Behring
Sterility assurance oversight
Gxp fda eu regulatory compliance
Microbial contamination control strategy
This strategic position executes Sterility Assurance oversight to ensure sites operate in compliance with the highest standard regulatory expectations
Job Summary
This strategic position executes Sterility Assurance oversight to ensure sites operate in compliance with the highest standard regulatory expectations.
The role involves developing and leading Sterility Assurance Roadmaps while providing expert input on major deviation investigations in sterile filtration and aseptic filling.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies and a culture of inclusion and belonging.
Matching Summary
This strategic position executes Sterility Assurance oversight to ensure sites operate in compliance with the highest standard regulatory expectations.
Skills & Requirements
Must-have
Sterility assurance oversight
GxP FDA EU regulatory compliance
Microbial contamination control strategy
Aseptic filling and lyophilization expertise
Global inspection readiness management
Nice-to-have
Proactive risk management culture
Cross-functional collaboration skills
Continuous improvement mindset
Strategic project leadership abilities
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