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)