Global Sterility Assurance Systems & Standards 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

Reporting to the Head of Global Sterility Assurance, this strategic position sits in the Global Quality Operations organisation. Ensuring the quality, safety and reliable supply of our products’ pipeline is critical. This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations.

By driving sterility assurance across partnering functions, this position ensures consistent standards, proactive risk management, and global inspection readiness.

Responsibilities

• Provide strategic leadership to the site related to sterility assurance standards, culture and continuous improvement
• Perform effective regulatory and business intelligence about sterile manufacturing and Sterility Assurance
• Work collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site
• Partner closely with the global function leads as well as site leadership team, develop strategies to ensure continuous adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements
• Provide expert input to Sterility Assurance related major deviation investigations in the area of sterile filtration, aseptic filling and lyophilization and sterility, media fill and bioburden test fail
• Proactively work with sites and global stakeholders on inspection readiness for the sites (before, during and after inspections)
• Provide CMOs and filling strategies Sterility Support (CMO selection process, technologies intelligence…)
• Provide strong Sterility Assurance background and support on strategic CSL projects (i.e. new filling lines selection and design)
• Develop and lead Sterility Assurance Roadmaps for compliance and performance
• Ensure appropriate development, implementation and maintenance of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards.
• Align and facilitate collaboration across Technical Operations, Quality functions, Operations, and R&D, to successfully drive aseptic excellence

Qualifications

• Bachelor’s degree in microbiology or biology or life sciences or equivalent relevant field
• 8-10 years' experience in pharmaceutical manufacturing industry with direct experience executing quality assurance within a manufacturing and QC microbiology, sterility assurance context
• Demonstrated experience in quality assurance and regulation compliance with GxP, FDA, EU and other regulatory agency guidelines
• Experience interacting with regulatory authorities including submissions and inspections; knowledge of auditing practices and procedure

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.