Global Sterility Assurance Systems & Standards Lead
CSL Limited
Multiple Locations
On-site
Sterility assurance systems & standards
Microbial contamination control strategy
Regulatory compliance
CSL Limited is seeking a Global Sterility Assurance Systems & Standards Lead to oversee sterility assurance standards and ensure compliance with regulatory expectations across its sites. The role emphasizes strategic leadership, collaboration, and proactive risk management in sterile manufacturing processes
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.
Ensure appropriate development, implementation and maintenance of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards.
Matching Summary
Match Score: 85
CSL Limited is seeking a Global Sterility Assurance Systems & Standards Lead to oversee sterility assurance standards and ensure compliance with regulatory expectations across its sites. The role emphasizes strategic leadership, collaboration, and proactive risk management in sterile manufacturing processes.
Skills & Requirements
Must-have
Sterility Assurance Systems & Standards
Microbial Contamination Control Strategy
Regulatory Compliance
Aseptic Filling and Lyophilization
Inspection Readiness
Nice-to-have
Strategic Leadership
Continuous Improvement
Risk Management
Cross-functional Collaboration
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