Global Sterility Assurance Systems & Standards Lead
CSL Behring
Sterility assurance standards implementation
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 expectations
Job Summary
This strategic leadership role executes sterility assurance oversight to ensure CSL sites and CMOs operate in compliance with the highest regulatory expectations.
The position drives consistent standards, proactive risk management, and global inspection readiness across partnering functions including Technical Operations and R&D.
CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies delivered to over 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 expectations.
Skills & Requirements
Must-have
Sterility assurance standards implementation
GxP FDA EU regulatory compliance experience
Microbial contamination control strategy
Aseptic filling and lyophilization expertise
Regulatory inspection readiness management
Nice-to-have
Strategic partnership with global stakeholders
Proactive risk management culture
Continuous improvement mindset
Cross-functional collaboration skills
Key Requirements
Bachelor's degree in microbiology or life sciences
8-10 years pharmaceutical manufacturing QA experience
Direct experience in QC microbiology and sterility assurance
Demonstrated interaction with regulatory authorities and inspections