Global Sterility Assurance Lead — Strategy & Compliance

BioSpace; Kankakee (IL); On-site; USD 160,000 - 190,000; Full time

Job summary

CSL Behring seeks a Head of Global Sterility Assurance to lead sterility strategy across sites and CMOs, ensuring compliant, safe, and reliable products. This newly created role reports to the Head of Global Sterility Assurance within Global Quality Operations.

You will drive cross-functional collaboration, implement best practices, and lead readiness for regulatory inspections, while shaping roadmaps and governance for sterility across the enterprise.

Qualifications

• Bachelor's degree in microbiology or life sciences or equivalent.
• 8–10 years in pharma manufacturing with QA, sterility context.
• GxP and FDA/EU regulatory compliance experience.
• Experience with regulatory authorities, submissions, inspections, auditing.

Responsibilities

• Provide strategic leadership on sterility assurance at the site.
• Perform regulatory and business intelligence on sterile manufacturing.
• Collaborate with global teams to implement contamination control strategy.
• Develop strategies with site leadership to maintain regulatory and CSL standards.
• Input to major deviation investigations in sterile processes.
• Prepare sites for inspections before, during, and after.
• Provide Sterility Support for CMOs and filling strategies.
• Support CSL projects with Sterility Assurance expertise.
• Develop Sterility Assurance roadmaps for compliance and performance.
• Maintain sterility standards and processes per governance and regs.
• Align across Technical Operations, Quality, Ops, and R&D for aseptic excellence.

Skills

Sterility Assurance

Quality Assurance

Regulatory compliance

FDA/EU regulatory knowledge

Auditing

Education

Bachelor's degree in microbiology or biology or life sciences or equivalent relevant field

Job description

CSL Behring seeks a Head of Global Sterility Assurance to lead sterility strategy across sites and CMOs, ensuring compliant, safe, and reliable products. This newly created role reports to the Head of Global Sterility Assurance within Global Quality Operations.

You will drive cross-functional collaboration, implement best practices, and lead readiness for regulatory inspections, while shaping roadmaps and governance for sterility across the enterprise.