患者さんのためにあなたの力を発揮してください
Job Summary
Primary Purpose / Regulatory Responsibilities:
The External Manufacturing Operations Lead Drug Products and Devices has responsibility for the overall performance of the CMOs and critical suppliers within their portfolio.
i. Reliability of the CDMO/supplier to deliver on supply commitments
ii. Robustness of the manufacturiung processes in all technical, GMP and regulatory aspects
iii. Responsiveness to issues within manufacturing – ensuring expertise is available to quickly recover from issues
iv. Relationships with stakeholders – foundational to ensure performance of cross functional and matrix teams
The EMOL leads the UCB Vendor Team and acts as the primary point of contact and relationship manager with the CMO
The role is accountable for the ultimate performance of the CDMO and as such acts as UCBs 'Virtual Site Head', coordinating the necessary internal resources and setting the priorities to meet the needs of UCBs downstream supply requirements and operations
The EMOL will have a deep understanding of all manufacturing and technical aspects relating to the sites within their portfolio, but will also have an appreciation of the business drivers of the sites.
The role will include the close interaction with other UCB functions as the CDMO / Manufacturing Operations SME on key projects and strategic initiatives delivered across the external manufacturing network
Scope:
Global CDMOs and strategic vendors selected for / active in development and commercial manufacturing of Drug Products and Medical Devices, across all dosage forms and device technology areas
Major Responsibilities
Ensure performance of a defined portfolio of CDMO's /strategic vendors.
This is achieved by ensuring reliability to deliver the manufacturing plans, robustness of the processes, responsiveness to issues and building strong relationships with Vendors and internal stakeholders.
Lead the CMO Vendor Teams coordinating cross-functional and inter-company activities including assessment of capability/development and resourcing needsLead or participate in transversal initiative/project to develop the operational excellence culture into UCB External Manufacturing.
Maintain the appropriate governance structures with their portfolio of CDMOs and lead the periodic meetings between CMOs and UCB multifunctional teams.
Perform the regular operational performance evaluation and management processes of the CDMO's in his/her portfolioProvide the technical expertise to support UCB's CDMO in order to ensure effective processes, optimize capacity utilization and deliver according to state-of-the-art quality standard.
Perform 1st line troubleshooting at CDMO in scope and lead investigations and CAPA implementation in case of complex, business relevant technical and supply issues.
Identify continuous improvement and performance improvement opportunities at the CDMO, develop the long-range plans and budgets associated, and deliver the projects to achieve improved quality, cycle times and reduced cost of goods.
Ensure compliance to regulatory standards and industry regulations, implementing best practices, and fostering a strong culture of compliance to always ensure inspection readiness at CDMOs within his/her portfolio.
By preparing the Business and Operations Plan, define the operational management & commercial strategy of the CDMO/suppliers in scope for the coming years.
Define and manage risk at the CMOs, including capacity availability and potential supply chain disruptionsMonitor underlying CDMO capacities and implement Products long range plans in coordination with relevant UCB functions. Where appropriate, represent EMP in the monthly brand supply review meetings
Maintain and share technology knowledge, market intelligence and product knowledge of outsourced manufacturing activities at CDMOs
The role may also include the line management of EMOLs
Education Level :
Master's Degree
COMPETENCIES
Subject matter expert in technical / manufacturing aspects related to the portfolio area
Ability to lead multi-functional teams, influence others, hold teams accountable, results orientated, effective at networking.
Must be able to manage external business partners and relationships to influence partners to deliver results that UCB needs. Includes negotiation skills and leadership presence as representative of UCB in discussion with senior management members of CMO's
Financial & business knowledge:
capable to develop and analyze business cases
Able to understand and get clear picture on complex, technical and manufacturing performance issues.
Capable to clearly summarize and present scenarios to support decision-making at senior management level
Fluent in English (written & spoken)
Influencing and persuasion skills
Ability to drive internal cross-functional teams
Fully self-directed
Experience in crisis management and associated communication
Capable of balancing long-term planning / anticipation of risks with responsiveness to immediate issues
Strong both analytical and conceptual thinking
Experience in Operational Excellence
Make your mark for patients
患者さんのためにあなたの力を発揮してください
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Saitama UCBThe External Manufacturing Operations Lead Drug Products and Devices has responsibility for the overall performance of the CMOs and critical suppliers within their portfolio. · ...
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