Global Sterility Assurance Systems & Standards Lead
CSL Behring
Sterility assurance oversight and support
Microbial contamination control strategy
Major deviation investigations
This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations
Job Summary
This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations.
By driving sterility assurance across partnering functions, this position ensures consistent standards, proactive risk management, and global inspection readiness.
The company is a global biotherapeutics leader driven by its promise to save lives, focused on serving patients’ needs by using the latest technologies to discover, develop and deliver innovative therapies.
Matching Summary
This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations.
Skills & Requirements
Must-have
Sterility Assurance oversight and support
microbial contamination control strategy
major deviation investigations
inspection readiness
CMO and filling strategies support
Sterility Assurance Roadmaps
Nice-to-have
strategic leadership
continuous improvement culture
proactive risk management
collaboration across functions
Key Requirements
8-10 years' experience in pharmaceutical manufacturing
Bachelor’s degree in microbiology or biology or life sciences
GxP, FDA, EU regulatory agency guidelines experience
Experience interacting with regulatory authorities