Global Sterility Assurance Systems & Standards Specialist
cslbehring.ch
Sterility assurance standards
Microbial contamination control strategy
Regulatory and business intelligence
Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement
Job Summary
Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement.
Partners closely with the global function leads as well as site leadership team, develops strategies to ensure continuous adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.
Matching Summary
Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement.
Skills & Requirements
Must-have
sterility assurance standards
microbial contamination control strategy
regulatory and business intelligence
sterile filtration
aseptic filling
lyophilization
inspection readiness
Nice-to-have
strategic leadership
continuous improvement
holistic approach
culture of curiosity and empathy
Key Requirements
Bachelor's degree in Microbiology or Biology or life sciences
8-10 years' experience in pharmaceutical manufacturing
Experience in quality assurance and regulation compliance with GxP, FDA, EU
Experience interacting with regulatory authorities