We are looking for a Senior Associate Serialization who ensures the compliant and efficient execution of serialization processes in accordance with EU FMD, DSCSA, and other applicable regulatory requirements.  

What Your Day To Day Will Look Like

• Execute and monitor serialization processes in compliance with EU FMD, DSCSA, and country-specific regulations
• Act as a user for serialization IT systems (e.g., Avarto, Tracekey, Melior, LSPedia), ensuring secure, stable, and compliant system functionality
• Support managing and monitoring of master data (GTIN/GS1), product catalogs (e.g., BrandSync), and system configurations for new products and markets
• Coordinate serial number uploads and data exchange with regional hubs (e.g., EU Hub), authorities, CMOs, and wholesalers
• Support and partially coordinate onboarding of new products, CMOs, and regions (system configuration, testing, aggregation, documentation)
• Contribute to change control processes, periodic reviews, and validation activities in collaboration with QA and IT
• Support serialization alert investigations and prepare incident documentation
• Identify process or system improvement opportunities and propose optimization measures

Your Qualifications And Experience

• Execute and monitor serialization processes in compliance with EU FMD, DSCSA, and country-specific regulations 
• Act as a user for serialization IT systems (e.g., Avarto, Tracekey, Melior, LSPedia), ensuring secure, stable, and compliant system functionality 
• Support managing and monitoring of master data (GTIN/GS1), product catalogs (e.g., BrandSync), and system configurations for new products and markets 
• Coordinate serial number uploads and data exchange with regional hubs (e.g., EU Hub), authorities, CMOs, and wholesalers 
• Support and partially coordinate onboarding of new products, CMOs, and regions (system configuration, testing, aggregation, documentation) 
• Contribute to change control processes, periodic reviews, and validation activities in collaboration with QA and IT 
• Support serialization alert investigations and prepare incident documentation 
• Identify process or system improvement opportunities and propose optimization measures 

Our offer

• An open corporate culture with the opportunity to contribute your own ideas
• Working independently in a collegial and committed team
• Modern working environment with good public transport connections (U4 - Heiligenstadt)
• Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
• Structured onboarding and support through a buddy system
• Due to legal requirements, we are obliged to disclose the collective agreement minimum salary, which is EUR 45.080,- gross per year, based on full-time employment. However, our actual remuneration packages are market-oriented and aligned with your qualifications and professional experience.