Global Sterility Assurance Systems & Standards Specialist
CSL Limited
Not specified (assume hybrid or onsite based on industry standards)
Sterility assurance standards
Microbial contamination control strategy
Regulatory and csl standards adherence
CSL Limited is seeking a Global Sterility Assurance Systems & Standards Specialist to lead sterility assurance standards and continuous improvement in a pharmaceutical manufacturing context. The ideal candidate will have extensive experience in quality assurance, regulatory compliance, and collaboration with global teams, particularly in sterile manufacturing
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
Match Score: 85
CSL Limited is seeking a Global Sterility Assurance Systems & Standards Specialist to lead sterility assurance standards and continuous improvement in a pharmaceutical manufacturing context. The ideal candidate will have extensive experience in quality assurance, regulatory compliance, and collaboration with global teams, particularly in sterile manufacturing.
Skills & Requirements
Must-have
sterility assurance standards
microbial contamination control strategy
regulatory and CSL standards adherence
sterile filtration
aseptic filling
lyophilization
media fill and 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