Global Sterility Assurance Systems & Standards Specialist

Job description

Responsibilities: Perform effective regulatory and business intelligence about sterile manufacturing and Sterility Assurance Proactively works with sites and global stakeholders on inspection readiness for the sites (before, during and after inspections) Provides CMOs and filling strategies Sterility Support (CMO selection process, technologies intelligence…) Provides strong Sterility Assurance background and support on strategic CSL projects (i.e. new filling lines selection and design) Develops and leads Sterility Assurance Roadmaps for compliance and performance Qualifications: Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. - Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement - Work collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site - Partners closely with the global function leads as well as site leadership team, develops strategies to ensure continuous adherence to regulatory and CSL standards rela...