Global Sterility Assurance Systems & Standards LeadReporting 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 improvementPerform effective regulatory and business intelligence about sterile manufacturing and Sterility AssuranceWork collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the sitePartner 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 improvementsProvide 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 failProactively 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 performanceEnsure 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 excellenceQualifications:Bachelor's degree in microbiology or biology or life sciences or equivalent relevant field8-10 years' experience in pharmaceutical manufacturing industry with direct experience executing quality assurance within a manufacturing and QC microbiology, sterility assurance contextDemonstrated experience in quality assurance and regulation compliance with GxP, FDA, EU and other regulatory agency guidelinesExperience interacting with regulatory authorities including submissions and inspections; knowledge of auditing practices and procedureDifferent qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Not specified in the original listing.
Not specified in the original listing.
CSL is a global biotechnology company focused on discovering, developing and delivering innovative medicines for people with serious and chronic medical conditions. They emphasize research and development in the fields of immunology, hematology, and... Read More