Global Sterility Assurance Systems & Standards Lead
CSL Behring
Sterility assurance oversight for sterile manufacturing
Gxp fda eu regulatory compliance experience
Microbial contamination control strategy development
This strategic leadership role executes sterility assurance oversight to ensure sites operate in compliance with the highest standard regulatory expectations
Job Summary
This strategic leadership role executes sterility assurance oversight to ensure sites operate in compliance with the highest standard regulatory expectations.
The position drives sterility assurance across partnering functions to ensure consistent standards, proactive risk management, and global inspection readiness.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies for patients worldwide.
Matching Summary
This strategic leadership role executes sterility assurance oversight to ensure sites operate in compliance with the highest standard regulatory expectations.
Skills & Requirements
Must-have
Sterility assurance oversight for sterile manufacturing
GxP FDA EU regulatory compliance experience
Microbial contamination control strategy development
Aseptic filling and lyophilization expertise
CMO selection and technology intelligence
Nice-to-have
Proactive risk management capabilities
Global inspection readiness preparation
Cross-functional collaboration skills
Continuous improvement culture drive
Strategic project leadership abilities
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