Global Sterility Assurance Systems & Standards Specialist
CSL Behring
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Sterility assurance standards
Microbial contamination control strategy
Regulatory and csl standards adherence
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CSL Behring is seeking a Global Sterility Assurance Systems & Standards Specialist to provide strategic leadership in sterility assurance, ensuring compliance with regulatory standards and continuous improvement. The ideal candidate should possess a strong background in microbiology and quality assurance within a pharmaceutical manufacturing context, with significant experience in regulatory interactions. This role offers an opportunity to impact patient care through innovative therapies while promoting a culture of inclusion and belonging.
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Job Summary
Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement.
Work collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives.
Matching Summary
Match Score: 75
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CSL Behring is seeking a Global Sterility Assurance Systems & Standards Specialist to provide strategic leadership in sterility assurance, ensuring compliance with regulatory standards and continuous improvement. The ideal candidate should possess a strong background in microbiology and quality assurance within a pharmaceutical manufacturing context, with significant experience in regulatory interactions. This role offers an opportunity to impact patient care through innovative therapies while promoting a culture of inclusion and belonging.
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Skills & Requirements
Must-have
sterility assurance standards
microbial contamination control strategy
regulatory and CSL standards adherence
sterile filtration
aseptic filling
lyophilization
sterility testing
media fill testing
bioburden testing
Nice-to-have
strategic leadership
continuous improvement
inspection readiness
CMO selection process
inclusion and belonging
Key Requirements
Bachelor's degree in Microbiology or Biology or life sciences
8-10 years' experience in pharmaceutical manufacturing
Quality assurance within manufacturing and QC microbiology