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Material Qualification Specialist

Boston, Massachusetts

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Material Qualification Specialist

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Job ID R0021818 Date posted 07/31/2020 Location Boston, Massachusetts

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Job Description

OBJECTIVES/PURPOSE :

  • Support a patient-focused global Material lifecycle management program for internal and external Material Qualification efforts, which is innovative, scalable and consistent. 
  • Oversight for global Material Qualification strategy and knowledge management.
  • Support the Global Supplier Notification of Change, Material Change Management and Excipient Risk Assessment Programs
  • Identify and implement Material Qualification continuous improvement enterprise solutions across the global network.

ACCOUNTABILITIES :

  • Support global MQ network (internal and external) as SME, providing training, inspection support, change assessment support and overall project technical and strategy expertise as required.
  • Support cross-functional MQ initiatives to enable optimization of working capital within the commercial portfolio.
  • Lead analysis (such a SWOT) of publicly available business intelligence (10-Ks, journals, etc.) to identify business trends, opportunities and requirements in material selection, implementation and qualification.  Communicate results to senior leadership on a routine basis.
  • Collaborate with other GMS leadership functions such as Strategy & Business Excellence on developing an end to end product manufacturing network strategy.
  • Lead and coordinate MQ global knowledge management activities throughout MQ network.
  • Deliver patient-focused lifecycle management priorities

DIMENSIONS AND ASPECTS

  • Analyze unstructured problems, identify root causes and align team objectives to drive divisional goals
  • Use agile principles to reduce process complexity and increase organizational capacity
  • Knowledge of Project Management and Process Improvement methodologies (Agile, Lean, DMAIC, Waterfall, and/or PMBOK)
  • Knowledge of essential CMC activities
  • Develop and apply custom strategies for processing and visualizing multidimensional data
  • Experience capturing and translating business requirements into technical solutions

Leadership

  • Experience managing projects in a matrix environment
  • Ability to inspire others to share their vision and support them to reach a common goal
  • A firm grasp of organizational development and cross-functional group alignment

Decision-making and Autonomy

  • Exercise judgment within defined procedures and practices to determine appropriate action.
  • Work in a dynamic environment, be able to set, balance and communicate priorities, and serve as a change agent.
  • Create functional strategies and goals that are closely aligned with Takeda’s objectives and develops metrics to track and assess performance.
  • Develops concise, strategic plans based on a clear understanding of the organization’s strengths, weaknesses, opportunities and threats.

Interaction

  • Exerts influence on the overall objectives and long-range goals of the organization.
  • Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations.
  • Strong interpersonal and active problem-solving skills
  • Engage partners to deliver agile and predictive results within a complex and evolving business landscape
  • Interface with each Operating Unit and Region supporting lifecycle management of development and commercially approved products
  • Build productive working relationships internally and externally.  

Innovation

  • Leverage business analytics (such as SWOT) to identify emerging opportunities and capability needs for GMSci.
  • Ability to apply first principles in chemistry, physics, and engineering to manufacturing problems and create new solution paths to manufacturing challenges.
  • Translate prior knowledge into new understanding of the development pipeline and expand the working knowledge of the essential activities for all key functional areas
  • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.

Complexity

  • Understands differences in practices across organizations or countries, and balances local demands and perspectives with global strategies.
  • Creates an environment that promotes information exchange and the open and honest expression of opinions, thoughts and beliefs.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0021818

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