Global Sterility Assurance Systems & Standards Lead

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

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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.