Global Sterility Assurance Systems & Standards Lead

About the role

Reporting to the Head of Global Sterility Assurance, this strategic position sits in the Global Quality Operations organisation. The role ensures the quality, safety, and reliable supply of our products’ pipeline by executing Sterility Assurance oversight and support to CSL sites and CMOs, ensuring compliance with the highest standard regulatory expectations. This newly created leadership role drives sterility assurance across partnering functions, ensuring consistent standards, proactive risk management, and global inspection readiness.

Responsibilities

• Provide strategic leadership to sites related to sterility assurance standards, culture, and continuous improvement.
• Perform effective regulatory and business intelligence about sterile manufacturing and Sterility Assurance.
• Work collaboratively with global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site.
• Partner closely with global function leads and site leadership teams to develop strategies ensuring 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 areas of sterile filtration, aseptic filling, lyophilization, sterility, media fill, and bioburden test failures.
• Proactively work with sites and global stakeholders on inspection readiness (before, during, and after inspections).
• Provide Sterility Support to CMOs and filling strategies (CMO selection process, technologies intelligence, etc.).
• Provide strong Sterility Assurance background and support on strategic CSL projects (e.g., 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, biology, life sciences, or an equivalent relevant field.
• 8-10 years' experience in the 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 procedures.

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