Serialisation and Artwork Specialist

We are looking for a Serialisation and Artwork Specialist to coordinate serialisation activities and support the end-to-end artwork process across Shionogi Europe. Working across products, markets and regions, you will help ensure compliant product supply, timely implementation of packaging changes, successful product launches and ongoing supply continuity.

Reporting to the Associate Director, Supply Chain Operations, you will work closely with Supply Chain, Quality Assurance, Regulatory Affairs and Procurement, as well as CMOs, packaging partners and serialisation service providers. You will ensure that packaging materials and serialisation data are accurate, compliant, implemented on time and aligned with business and regulatory requirements.

Key Responsibilities:

• Serialisation management
  Manage serialisation activities in line with EU FMD and applicable local legislation. Coordinate with serialisation service providers, NMVOs and external partners; maintain product, country, batch and serial-number master data; manage Rfxcel; support onboarding of new products, markets, CMOs and logistics partners; and monitor costs and invoicing.
  
  
• Artwork management
  Support new artwork, changes and maintenance throughout the artwork lifecycle. Align technical drawings, keylines, texts and packaging components with Quality Assurance, Regulatory Affairs and packaging partners, and monitor timelines for launches, variations and supply continuity.
  
  
• Change control and compliance
  Support artwork-related change controls, documentation and impact assessments. Ensure activities meet GxP requirements, internal SOPs and relevant EMA, MHRA and EU FMD requirements.
  
  
• Stakeholder and vendor coordination
  Act as a key contact for serialisation and artwork across Shionogi Europe, building effective relationships with internal teams, CMOs, packers, vendors and IT or serialisation providers.

We are looking for a candidate with excellent organisation and coordination skills, with the ability to manage several priorities and projects in parallel. You have a high attention to detail and a strong quality mindset. In your work you have a structured, disciplined and accurate approach to work. You take ownership, initiative and have a practical, problem-solving way of working. Because you work across functions, you have the ability to build effective relationships across geographies and with external partners. Although we work in a time-sensitive environment, you have a calm and adaptable approach and a continuous-improvement mindset. You carry the confidence to constructively challenge inefficient processes.

Requirements:

• A bachelor’s degree, or equivalent experience, in life sciences, pharmaceutical operations, supply chain, packaging, technical operations or another regulated environment.
• At least three years of relevant experience in the pharmaceutical industry or another regulated environment.
• Demonstrable knowledge of pharmaceutical serialisation and artwork processes, including EU FMD.
• Knowledge of GxP requirements and change-control processes.
• Experience working cross-functionally in a matrix organisation.
• Experience supporting product launches across multiple European markets.
• Knowledge of ERP and serialisation systems, including master-data management; experience with Rfxcel is a plus
• Strong written and spoken English.