Other Locations:Switzerland- Boudry
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Manager / Sr. Manager, Serialization Operations
Global Supply Planning, Logistics and Master Data
A four-year Bachelor’s degree or equivalent is required, preferably in Supply Chain, Logistics, or Systems. Advanced degree preferred.
10 years’ experience in pharmaceutical supply chain and/or related technology systems management preferably within a distribution operations environment.
1 - 3 years supervisory experience preferred
Prior experience in managing projects associated with supply chain ERP systems (Oracle - preferred or SAP), related boundary applications, supply chain processes and global serialization requirements.
The Manager / Sr. Manager of Serialization Operations will assemble and manage cross functional teams across IT, Packaging, Engineering, Labelling (Internal & External), Quality Assurance, Supply Planning, Master Data, Logistics (Internal & External), and Project Management, ensuring smooth and transparent serialization, track and trace, and FMD implementations across Celgene global operations. This position plays a key role within Global Pharmaceutical Development & Operations to ensure Global Supply and is responsible for defining and leading the execution of the Global Serialization strategy. The incumbent will assure sustainable and scalable programs that deliver regulatory compliance in all markets, while managing the growth and quality of data and maintaining production and logistical efficiencies.
Responsibilities include, but are not limited to, the following:
- Global lead to implement track, trace and serialization initiatives into Celgene product supply & distribution operations
- Manage serialization readiness & operations teams and partner with internal business counterparts to insure serialization solution and processes meet regulatory timelines and deliverables
- Develop a global, repeatable, & sustainable process to effectively resolve issues arising from the installation and operation of Serialization hardware components in both packaging and logistics operations
- Maintain current knowledge & awareness of global market serialization regulations and adapt Celgene practices to comply with regulations
- Develop and maintain a collaborative environment for serialization operations & compliance including Logistics Strategy, Master Data Management, Global Product Security, Global Supply Planning, Internal/External Manufacturing, Marketing, Sourcing, Information Technology and Quality
- Develops and manages an accurate global serialization budget, including capital appropriations
- Proactively manage changes in project scope or schedule and assess their impact on budgets, business processes or other initiatives
- Develop and execute an effective communication strategy for global serialization status updates
- Track and monitor team progress including coordination of project team members, consultants and subject matter experts in the design, execution and post go-live support activities and take steps to remediate issues that adversely impact Serialization project budgets, schedules and deliverables
- Develop and author standard operating procedures and/or work practice documents
- Facilitate global training development and implementation
- Partner with Global Product Security in controlling and monitoring product serialization in highly complex distribution networks
- Identify systems and resource needs to effectively support and sustain the global serialization program
- Responsible for the management of serialization solution provider
- Facilitate integration between global CMOs, LSPs, and customers with the serialization solution provider
- Act as Serialization business process lead for piloting and testing in various countries
- Facilitate serialization data management & issue resolution
- Conduct serialization process performance monitoring & reporting
- Multilingual preferred
- Prior experience in pharmaceutical serialization initiatives
- Demonstrated ability to manage and deliver complex global projects
- Knowledge within all areas associated with serialization including EPCIS, GS1 serialization and track and trace standards
- Ability to manage, set priorities, and successfully complete multiple projects concurrently
- Strong background in business operations and process controls
- Experience with Systems Management (disaster recovery, problem management, incident management, change management etc.)
- Experience with test strategy and execution of track and trace systems throughout the global supply chain
- Thorough understanding of best practices in Supply Chain operations, project management, master data management and GxP change controls
- Working knowledge of international pharmaceutical GxP regulatory requirements
- Ability to facilitate translation of business requirements and application capabilities
- Six Sigma and Lean Manufacturing experience a plus
- Willing to travel 20 - 40% domestically and internationally