Global Sterility Assurance Systems & Standards Lead
Seqirus
Sterility assurance oversight
Gxp regulatory compliance
Fda and eu guideline knowledge
This strategic leadership role ensures the quality, safety, and reliable supply of products by executing sterility assurance oversight across global sites and CMOs
Job Summary
This strategic leadership role ensures the quality, safety, and reliable supply of products by executing sterility assurance oversight across global sites and CMOs.
The position requires providing expert input to major deviation investigations involving sterile filtration, aseptic filling, and media fill failures while driving continuous adherence to regulatory standards.
As part of a global biotherapeutics leader, the role supports innovation in plasma fractionation and cell therapy platforms to address unmet medical needs for patients worldwide.
Matching Summary
This strategic leadership role ensures the quality, safety, and reliable supply of products by executing sterility assurance oversight across global sites and CMOs.
Skills & Requirements
Must-have
Sterility assurance oversight
GxP regulatory compliance
FDA and EU guideline knowledge
Aseptic filling and lyophilization expertise
Microbial contamination control strategy
CMO sterility support
Nice-to-have
Strategic leadership in quality operations
Proactive risk management culture
Global inspection readiness experience
Continuous improvement mindset
Cross-functional collaboration skills
Key Requirements
Bachelor's degree in microbiology or biology
8-10 years pharmaceutical manufacturing experience
Direct QA experience in sterility assurance context