Global Sterility Assurance Systems & Standards Lead
cslbehring.cl
Sterility assurance expertise in sterile manufacturing
Gxp fda eu regulatory compliance experience
Microbial contamination control strategy development
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 drives consistent global standards, proactive risk management, and inspection readiness across partnering functions including Technical Operations and Quality.
CSL Behring is a global biotherapeutics leader employing 32,000 people who deliver lifesaving therapies 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 standards.
Skills & Requirements
Must-have
Sterility assurance expertise in sterile manufacturing
GxP FDA EU regulatory compliance experience
Microbial contamination control strategy development
Aseptic filling and lyophilization knowledge
Regulatory inspection readiness management
Nice-to-have
Strategic project leadership in new filling lines
CMO selection and technology intelligence skills
Cross-functional collaboration with R&D teams
Proactive risk management culture building
Key Requirements
Bachelor's degree in microbiology or biology
8-10 years pharmaceutical manufacturing QA experience
Direct experience in QC microbiology and sterility assurance
Demonstrated interaction with FDA and EU regulatory agencies