Serialisation and Artwork Specialist
Key Skills
Job Description
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.
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. 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.
- 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.
Core Responsibilities
Coordinate serialisation activities and manage the end-to-end artwork process to ensure compliant product supply and timely launches. Collaborate with internal functions and external partners to maintain accurate master data and ensure adherence to regulatory requirements.
Requirements
Requires a bachelor's degree in a relevant field and at least three years of experience in the pharmaceutical or regulated industry. Candidates must possess demonstrable knowledge of serialisation, artwork processes, GxP requirements, and change-control procedures.
About Shionogi BV
Industry: Pharmaceutical Manufacturing
Company size: 201-500 employees
Shionogi B.V. (known as “Shionogi Europe”) is the European headquarters of Shionogi & Co., Ltd, a leading global research-driven pharmaceutical company based in Osaka, Japan. Since 1878, Shionogi has been striving to supply the best possible medicines to protect the health and wellbeing of the patients we serve. We are dedicated to finding innovative solutions for pressing unmet clinical needs, and have a strong track record in discovering and developing novel medicines for antimicrobial resistance (AMR), HIV and influenza. Alongside our work in infectious diseases, we also have extensive expertise in other areas of unmet clinical needs within our Hospital Specialty Business, and a strong track record in other therapy areas affecting quality of life, particularly Women’s Health. Since launching in Europe in 2012, we have significantly expanded our presence and now have coverage of the biggest markets in the continent. Our offices in Amsterdam, Berlin, London, Madrid, Paris and Rome provide the bases for over 300 passionate staff from across the spectrum of big pharma and biotech, as well as experts in technology, creatives, entrepreneurs and others - who come together to do things differently and better. Our culture is unique, blending our Japanese roots with our strong and rapidly growing European operation. We have a friendly, inclusive work environment and aim to foster a culture that encourages our people to break out of the boundaries of the traditional pharmaceutical company. Through successful strategic partnerships and open collaboration, we are determined to shape the future of healthcare. Our ambitious growth plans include extending the reach of our marketed products, developing our innovative pipeline of medicines and securing the right partnerships and acquisitions to accelerate our development. To find out about partnering with us, visit: https://t.ly/YzlSu For career opportunities, visit: https://t.ly/mERcQ NP-EU-NP-0303 DOP July 2024