SERIALIZATION LEAD

We are a growing pharmaceutical company specialized in the manufacturing of sterile injectable products with terminal sterilization. We operate both as a manufacturer and as a Contract Manufacturing Organization (CMO), supporting international clients in the development and production of high-quality injectable medicines. We are looking for an experienced and motivated

Serialization Lead. Key Responsibilities Own and execute the serialization roadmap, supporting change management activities Ensure compliance with EU FMD, US DSCSA, Chinese serialization requirements, and other applicable global regulations Manage serialization system lifecycle activities including configuration, master data setup, CSV/CPV, and change control Act as escalation point for serialization and aggregation issues at the site and external partners, ensuring system stability (Level 1 – 4 architecture) Support regulatory inspections, customer audits, and internal compliance assessments Develop and maintain SOPs, validation documentation, and training materials in line with GMP requirements Monitor serialization KPIs and drive continuous improvement initiatives Profile 5+ years of experience in pharmaceutical manufacturing and/or packaging (ideally sterile injectables) Solid experience in pharmaceutical serialization within GMP environments Strong knowledge of EU FMD, US DSCSA, and familiarity with Chinese serialization requirements Experience in Computer System Validation (CSV), change control, and validation activities Understanding of labelling requirements, barcode standards, and serialization systems Strong project management and problem-solving skills in multi-stakeholder environments Ability to manage multiple priorities in a fast-paced global CMO context Fluent English (written and spoken)