Global Sterility Assurance Systems & Standards Lead
CSL
Multiple Locations
Sterility assurance oversight and support
Microbial contamination control strategy
Regulatory and csl standards adherence
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
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.
Align and facilitate collaboration across Technical Operations, Quality functions, Operations, and R&D, to successfully drive aseptic excellence.
Matching 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.
Skills & Requirements
Must-have
Sterility Assurance oversight and support
microbial contamination control strategy
regulatory and CSL standards adherence
major deviation investigations
inspection readiness for sites
CMO and filling strategies support
Nice-to-have
strategic leadership
continuous improvement culture
proactive risk management
aseptic excellence collaboration
Key Requirements
8-10 years' experience in pharmaceutical manufacturing
Bachelor’s degree in microbiology or biology or life sciences
GxP, FDA, EU regulatory guidelines experience
Experience interacting with regulatory authorities