Serialization System Owner, Supply Chain - Switzerland
|External Posting Title||Serialization System Owner, Supply Chain|
|Job Description||Overview |
This role will act as business owner of Biogen's Global serialization system, which is used to meet packaging, data and supply chain security compliance requirements for a number of global markets including the USA and EU. It includes responsibility for all operational aspects, including system, quality and support aspects.
This role will design and own the data connectivity strategy with supply chain partners (CMO’s, 3PL’s, Distributors, etc.) as well as national and supernational compliance databases, including 28+ databases in Europe, Russia, Brazil and other markets with emerging regulations, while assuring that the design and implementation meets specific market, business and regulatory drivers.
Work will include cooperating with government authorities regarding suspected counterfeit activities, participation in appropriate working groups and teams within and outside of Biogen on related topics, as well as monitoring of global regulations having an impact on serialization and traceability capabilities.
This role will act as senior subject matter expert for quality, master data, data management, and data exchange topics, with impact on serialization.
• Accountable as business owner of the EPCIS serialization system for system readiness, system use, data connectivity, product traceability and product lifecycle management.
• Business owner for serialization data communication standards and implementations with Supply Chain partners.
• Provides the vision and strategy for Master data and ERP integration as it pertains to serialization.
• Accountable for operational support model; including operational procedures and user administration.
• Ensures global availability of serialization system in support of Biogen's supply chain operations, ensuring business continuity and patient supply.
• Provides training for operational use of serialization throughout Biogen. Authors serialization standards and policies. Monitors and reports on serialization operations metrics and resolves data issues.
• Acts as operational lead for Biogen global serialization services, including the role of quality sub-system business process owner. This includes accountability for data integrity, integration of serialization requirements into other business functions and participation in investigations related to serialization data.
• Acts as business data owner for relevant master data. Provide strategy on barcoding and data specification management
• Acts as senior subject matter expert for quality, data management and master data related questions and issues relating to serialization
• Develop accurate interpretation of regulatory intelligence and implementation f system and procedural capabilities, and lead any change required to meet compliance requirements in a timely manner. Participates in internal and external working groups focused on serialization, traceability and related topics.
|Job Category||Operations, Technology & Innovation (PO&T)|
• Minimum 8 years of of experience in biotech/pharmaceutical manufacturing industry, or in other industries that have demonstrably similar data systems, quality systems, data management and regulatory requirements.
• Minimum 3 years of experience operating in a Supply Chain management function.
• Fluent English is a must, any other European language is an asset
• Bachelors/Masters Degree (Life Science, Quality, Engineering, Business Administration or a related field). Master's Degree is preferred.
|About Biogen||Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. |
Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.
With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
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