Senior Associate Commercial Serialization
Accountable for the effective identification, investigation and resolution of alerts from scanned pharmaceutical product primarily across European countries. Handling of Issues and queries relating to the decommissioning of serialized packs at any point in the supply chain. Responsible for supporting all technical aspects of serialization including technical registration with national systems, master data definition and maintenance, and EPCIS activities in collaboration with external serialization partners. Additionally, this position will provide technical support for the planning and execution of any new projects globally, and function as the European region contact for serialization. An understanding of computer systems validation is desired to ensure that any packaging and labeling computerized systems (i.e. systems to support FMD and other regional requirements) are compliant with the Seattle Genetics quality systems as well as how to manage integration of data with other partners.
- Participate in the design and implementation of the long-term process to manage alerts from any source (IT systems, distributor, CMO, site, market)
- Monitor incoming alerts via European wide system (EU Hub) which come from national verification systems
- Manage Issues and queries related to serialized product which arise from manufacturing sites, Contract Manufacturers (CMO’s), 3PL’s/distributors, marketplace (Regulatory/Quality), Pharmacies and/or National authorities
- Support all technical and EPCIS activities associated with serialization
- Participates with both internal and external project teams related to Serialization and Product Security
- Assist in technical problem solving by collaborating with partners and Quality to resolve technical and compliance issues
- Participates in Computer System Validation efforts for new and ongoing programs as requested including but not limited to integration with CMO’s, Health Authorities, on-going process improvements for existing products
- Work with following internal departments: Global IT, Regulatory Affairs, Quality and Supply Chain
- External interactions: IT Serialization system supplier, European Medicines Verification Organisation (EMVO), various National Medicines Verification Organizations (NMVO’s), Distributors/wholesalers and CMOs as needed.
- Strong technical knowledge of commercial product serialization and GS1 standards including EPCIS
- Methodical / logical thinker with the ability to trouble-shoot issues to a resolution
- Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential within a matrixed global organization
- Ability to work on own initiative
- Knowledge and understanding of the Falsified Medicines Directive (FMD)
- Experience with, pharmaceutical quality systems.
- Systems validation experience is desired as well as working knowledge of cGMP, 21 CFR Part 11 and Annex 11
- Ability to travel ~10%
- BS/BA Degree in an IT, business or life science field and/or 5+ years of experience in commercial serialization, DSCA / FMD compliance, computer systems operations