Serialization Manager / Serialization System Owner

We are looking for a Serialization Manager / Serialization System Owner, who will have end-to-end responsibility for our serialization systems and processes, will ensure stable, GMP-compliant system operations and act as a key interface between IT, Quality, Packaging, external partners, and regulatory authorities, supporting global market requirements.

Act as System Owner for serialization-related IT systems (e.g. Avarto, Melior, LSPedia)

Ensure compliant system operation in a GMP environment, including:

• SOP management
• Change control
• Validation activities
• Periodic reviews
• User and access management
• Onboarding activities
• Manage connectivity to regulatory hubs and authorities (e.g. EU-Hub / EMVO, DSCSA)
• Coordinate serial number and master data exchange with authorities, CMOs, and wholesalers
• Administer products, SKUs, and product catalogs (e.g. GS1 standards, BrandSync)
• Support onboarding of new products and markets (e.g. GCC, US, LATAM)
• Implement system changes in collaboration with internal stakeholders and external vendors
• Support serialization-related projects and regulatory implementations
• Handle serialization alerts and support QA investigations and incident reporting
• Manage serialization-related fees and annual agreements with NMVOs
• Act as the primary point of contact for serialization topics for internal and external stakeholders

• Bachelor’s degree in Natural Sciences, Business Administration, Information Technology or a related field or comparable professional experience as a key user or system owner in complex IT environments
• Several years of experience with serialization systems or secondary packaging automation in a GMP-regulated environment
• Strong knowledge of pharmaceutical serialization regulations (EU FMD; DSCSA is an advantage)
• Confident handling of complex IT systems and interfaces
• Structured, precise, and independent working style
• Strong analytical and problem-solving skills
• Ability to clearly communicate technical and regulatory topics to diverse stakeholders
• High level of reliability and resilience in a regulated environment
• Very good English skills; additional languages are an advantage

• 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.