Global Sterility Assurance Systems & Standards Lead
Century Center
Multiple Locations
Sterility assurance oversight
Microbial contamination control strategy
Regulatory expectations
This strategic 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 strategic 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.
Responsibilities include providing strategic leadership, performing regulatory intelligence, partnering with global teams, and offering expert input to major deviation investigations.
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
This strategic 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
microbial contamination control strategy
regulatory expectations
aseptic excellence
CMO support
Nice-to-have
strategic leadership
continuous improvement culture
proactive risk management
inclusion and belonging
Key Requirements
8-10 years' experience
Bachelor's degree in microbiology or biology or life sciences
GxP, FDA, EU regulatory compliance
Experience interacting with regulatory authorities