Global Sterility Assurance Systems & Standards Lead
CSL Behring
8-10 years pharmaceutical manufacturing experience
Direct sterility assurance and qa execution
Gxp fda eu regulatory compliance knowledge
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 by collaborating with partnering functions and site leadership.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies for patients in immunology and hematology.
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
8-10 years pharmaceutical manufacturing experience
Direct sterility assurance and QA execution
GxP FDA EU regulatory compliance knowledge
Experience with sterile filtration and aseptic filling
Global inspection readiness management
Nice-to-have
Strategic leadership in continuous improvement
Proactive risk management capabilities
Collaboration across global functions
Expertise in microbial contamination control
Key Requirements
Bachelor's degree in microbiology or life sciences
8-10 years experience in pharmaceutical industry
Demonstrated GxP, FDA, and EU regulatory compliance
Experience interacting with regulatory authorities