Global Sterility Assurance Systems & Standards Lead
cslbehring.cz
Sterility assurance oversight for manufacturing sites
Gxp fda eu regulatory compliance expertise
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 standard regulatory expectations
Job Summary
This strategic leadership role executes sterility assurance oversight to ensure CSL sites and CMOs operate in compliance with the highest standard regulatory expectations.
The position drives consistent standards, proactive risk management, and global inspection readiness by collaborating with partnering functions across Technical Operations, Quality, and R&D.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, offering a culture of inclusion and belonging at its core.
Matching Summary
This strategic leadership role 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 for manufacturing sites
GxP FDA EU regulatory compliance expertise
Microbial contamination control strategy development
Aseptic filling and sterile filtration knowledge
Inspection readiness management for global sites
Nice-to-have
Proactive risk management capabilities
Strategic collaboration with CMOs
Continuous improvement culture leadership
Experience with new filling line design
Key Requirements
Bachelor's degree in microbiology or biology
8-10 years pharmaceutical manufacturing experience
Direct quality assurance in sterility assurance context
Experience interacting with regulatory authorities