Global Sterility Assurance Strategy Lead

CSL; Kankakee (IL); On-site; USD 150,000 - 210,000; Full time

Job summary

CSL is seeking a newly created leadership role in Sterility Assurance within its Global Quality Operations. This executive position drives sterility oversight across CSL sites and CMOs to meet top regulatory standards and ensure reliable supply of products.

The role partners with global teams to maintain inspection readiness, lead risk management, and guide continuous improvement in sterile manufacturing and bioburden control.

Qualifications

• Bachelor’s degree in microbiology, biology or life sciences or equivalent.
• 8–10 years in pharmaceutical manufacturing with QA in sterility assurance context.
• Experience with GxP, FDA, EU and other regulatory guidelines.

Responsibilities

• Provide strategic leadership to sterility assurance standards and continuous improvement at sites.
• Perform regulatory and business intelligence about sterile manufacturing and Sterility Assurance.
• Collaborate with global sterility assurance teams to develop a holistic contamination control strategy at the site.
• Partner with global function leads and site leadership to ensure adherence to regulatory CSL standards related to sterility assurance governance and drive improvements.
• Provide input to sterility assurance related deviation investigations in sterile filtration, aseptic filling, lyophilization, sterility, media fill and bioburden tests.
• Proactively work with sites on inspection readiness for inspections.
• Provide sterility support to CMOs and filling strategies (CMO selection, technology intelligence).
• Contribute to CSL strategic projects (new filling lines selection and design).
• Develop and lead Sterility Assurance Roadmaps for compliance and performance.
• Ensure development, implementation and maintenance of sterility assurance standards aligned with governance and regulatory requirements.
• Align with Technical Operations, Quality, Operations and R&D to drive aseptic excellence.

Skills

Quality Assurance

Regulatory Compliance

Auditing

Education

Bachelor’s degree in microbiology/biology/life sciences

Job description

CSL is seeking a newly created leadership role in Sterility Assurance within its Global Quality Operations. This executive position drives sterility oversight across CSL sites and CMOs to meet top regulatory standards and ensure reliable supply of products.

The role partners with global teams to maintain inspection readiness, lead risk management, and guide continuous improvement in sterile manufacturing and bioburden control.