Serialisation and Artwork Specialist

Shionogi Europe; Amsterdam; On-site; EUR 60,000 - 90,000; Full time

Job summary

Shionogi Europe is seeking a Serialisation and Artwork Specialist to coordinate serialisation activities and support end-to-end artwork processes across products, markets and regions. You will ensure compliant packaging, timely changes and ongoing supply continuity through close collaboration with QA, RA, Supply Chain and external partners.

The role requires a bachelor’s degree in a regulated field and at least three years of pharma experience, with strong English skills and willingness to

Qualifications

• Bachelor’s degree in a regulated field (life sciences/pharma) or equivalent experience.
• At least 3 years of relevant pharma/regulated industry experience.
• 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; English proficiency.

Responsibilities

• Coordinate serialisation activities in line with EU FMD and local rules; manage master data and external partners.
• Support artwork changes and maintenance across the lifecycle; align drawings and packaging components with QA, RA and partners.
• Assist with artwork-related change controls, documentation and impact assessments per EMA/EU FMD requirements.
• Act as a key contact for serialisation and artwork across Shionogi Europe with internal teams, CMOs, packers and IT/providers.

Skills

Organisational skills

Attention to detail

Project management

Cross-functional collaboration

English proficiency

Education

Bachelor's degree in life sciences / pharmaceutical operations / supply chain / packaging / technical operations

Tools

Rfxcel

ERP systems

Serialisation software

Job description

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.

Who Are We Looking For?

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.
• Able to travel into the office in Amsterdam at least 2 days/week

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.

Why Join Shionogi?

At Shionogi, we are committed to improving health and quality of life through innovative medicines and reliable patient access. Joining our European Commercial Supply Chain team means contributing to work that helps ensure medicines are packaged, verified and supplied accurately, compliantly and on time. You will collaborate across functions and with trusted external partners in an international, quality-focused environment where attention to detail and continuous improvement make a meaningful difference.