Global Sterility Assurance Systems & Standards Lead
CSL Behring
Sterility assurance oversight experience
Gxp fda eu regulatory compliance knowledge
Microbial contamination control strategy
This strategic position executes Sterility Assurance oversight to ensure CSL sites and CMOs operate in compliance with the highest standard regulatory expectations
Job Summary
This strategic position executes Sterility Assurance oversight to ensure CSL sites and CMOs operate in compliance with the highest standard regulatory expectations.
The role involves providing expert input to major deviation investigations in sterile filtration, aseptic filling, and bioburden test failures while driving global inspection readiness.
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 CSL sites and CMOs operate in compliance with the highest standard regulatory expectations.
Skills & Requirements
Must-have
Sterility Assurance oversight experience
GxP FDA EU regulatory compliance knowledge
Microbial contamination control strategy
Aseptic filling and lyophilization expertise
Regulatory inspection readiness management
Nice-to-have
Proactive risk management capabilities
Cross-functional collaboration skills
Continuous improvement culture drive
CMO selection process support
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