Global Sterility Assurance Systems & Standards Specialist
Seqirus
Multiple Locations
Sterility assurance standards leadership
Regulatory compliance with gxp, fda, eu
Microbial contamination control strategy
The role provides strategic leadership related to sterility assurance standards, culture, and continuous improvement at the site
Job Summary
The role provides strategic leadership related to sterility assurance standards, culture, and continuous improvement at the site.
The company CSL Behring is a global biotherapeutics leader focused on innovative therapies and operates one of the world’s largest plasma collection networks.
CSL fosters a culture of inclusion and belonging to drive innovation and sustain a diverse workforce.
Matching Summary
The role provides strategic leadership related to sterility assurance standards, culture, and continuous improvement at the site.
Skills & Requirements
Must-have
Sterility assurance standards leadership
Regulatory compliance with GxP, FDA, EU
Microbial contamination control strategy
Sterility assurance deviation investigations
Inspection readiness and regulatory interactions
Quality assurance in sterile manufacturing
Nice-to-have
Collaborative global team work
Continuous improvement culture
Strategic project support
Inclusion and belonging culture
Key Requirements
Bachelor's degree in Microbiology or Life Sciences
8-10 years pharmaceutical manufacturing experience
Experience with quality assurance and regulatory compliance
Experience with regulatory submissions and inspections