Global Sterility Assurance & Compliance Lead

CSL Plasma Inc.; Kankakee (IL); On-site; USD 180,000 - 230,000; Full time

Job summary

CSL Behring seeks a Global Sterility Assurance Systems & Standards Lead to drive site Sterility Assurance programs and global governance. The role oversees regulatory readiness, risk management, and collaboration with CMOs to ensure compliance with high standards.

You will influence aseptic processes, support major CSL projects, and lead roadmaps for sterility compliance across the globe.

Qualifications

• Bachelor’s degree in microbiology, biology or life sciences or equivalent.
• Experience executing quality assurance within manufacturing and QC microbiology/sterility context.

Responsibilities

• Provide strategic leadership to site related to sterility assurance standards, culture and continuous improvement
• Work collaboratively with global sterility assurance teams to develop holistic strategies and improvement plans
• Prepare sites for regulatory inspections and ensure compliance with CSL standards
• Support CMO strategies and filling line projects related to sterility
• Lead Sterility Assurance roadmaps for compliance and performance
• Ensure development and maintenance of sterility standards aligned with global governance and regulatory requirements
• Collaborate across Technical Operations, Quality, Operations and R&D to drive aseptic excellence

Skills

Sterility assurance

Regulatory compliance

GxP experience

FDA/EU regulatory knowledge

Auditing practices

Education

Bachelor’s degree in microbiology/biology/life sciences

Job description

CSL Behring seeks a Global Sterility Assurance Systems & Standards Lead to drive site Sterility Assurance programs and global governance. The role oversees regulatory readiness, risk management, and collaboration with CMOs to ensure compliance with high standards.

You will influence aseptic processes, support major CSL projects, and lead roadmaps for sterility compliance across the globe.