Global Sterility Assurance Systems & Standards Lead
CSL Behring
Multiple Locations
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Sterility assurance oversight and support
Microbial contamination control strategy
Regulatory expectations and standards
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CSL Behring is seeking a Global Sterility Assurance Systems & Standards Lead to oversee sterility assurance across its global operations and ensure compliance with regulatory standards. The ideal candidate will have extensive experience in pharmaceutical manufacturing and quality assurance, with a focus on sterility and regulatory compliance.
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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.
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 Lead to oversee sterility assurance across its global operations and ensure compliance with regulatory standards. The ideal candidate will have extensive experience in pharmaceutical manufacturing and quality assurance, with a focus on sterility and regulatory compliance.
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Skills & Requirements
Must-have
Sterility Assurance oversight and support
microbial contamination control strategy
regulatory expectations and standards
inspection readiness for sites
CMO and filling strategies support
aseptic excellence
Nice-to-have
strategic leadership
proactive risk management
continuous improvement
collaboration across functions
Key Requirements
Bachelor's degree in microbiology or biology or life sciences
8-10 years' experience in pharmaceutical manufacturing
Quality assurance and regulation compliance with GxP, FDA, EU
Experience interacting with regulatory authorities