Global Sterility Assurance Systems & Standards 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

Global Sterility Assurance Systems & Standards Lead

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. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

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. 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 click here.

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