Global Sterility Assurance Systems & Standards Lead
CSL Behring
Sterility assurance expertise
Gxp fda eu regulatory compliance
Microbial contamination control strategy
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 consistent standards, proactive risk management, and global inspection readiness across partnering functions and CSL sites.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies and advanced scientific platforms.
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 expertise
GxP FDA EU regulatory compliance
Microbial contamination control strategy
Aseptic filling and lyophilization knowledge
CMO selection and support experience
Nice-to-have
Strategic project leadership skills
Proactive risk management approach
Collaborative cross-functional teamwork
Continuous improvement culture mindset
Key Requirements
Bachelor's degree in microbiology or life sciences
8-10 years pharmaceutical manufacturing experience
Direct quality assurance experience in sterility context
Experience interacting with regulatory authorities