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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 2018.

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

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Director -Quality

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Job ID R0009809 Date posted 07/24/2019 Location Singapore, Singapore

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Job Description

ACCOUNTABILITIES (Describe the primary duties and responsibilities of the job.  Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).

  • Quality Management System (QMS)- feedback / implementation of Standards  / Procedures / etc.
  • Quality Risk Management –(governance / program oversight)
  • Metric and Performance Reporting
  • Quality Management Reviews / Councils
  • Product Quality Reports – (APQR)
  • Inspection Readiness Governance
  • Quality Compliance Governance (Continuous Improvements / Changing regulations)
  • GxP Learning and Training Governance
  • Digitization System Implementation Governance
  • Data Integrity Governance
  • Change Control processes( artwork/labeling as needed)
  • External Awareness – changing regulations/competitive intelligence
  • Self Assessment / inspection processes

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise(Breadth and depth of knowledge, application and complexity of technical knowledge)

  • Knowledge and experience of Bio-Pharmaceutical Research, Development, and Manufacturing
  • Deep knowledge and understanding of relevant regulations (FDA, EMA,SFDA,etc.) enabling effective partnerships across the network
  • Knowledge and understanding of global and local Quality and Regulatory concepts and requirements (e.g. ICH, EUGMP, Annex 1, Compendia, etc.)
  • Knowledge and understanding of relevant technologies and digital solutions desired
  • Knowledge and understanding of Local Operating Companies (LOC’s,)

Leadership(Vision, strategy and business alignment, people management, communication, influencing others, managing change)

  • Effective communicator
  • Ability to lead effectively through directing change as well as driving change by influence
  • Ability to lead and engage in complex investigations and propose sound, scientific, and compliant resolutions
  • Ability to act locally as well as engaging to support global activities

Decision-making and Autonomy(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving)

  • An active member of Operating Unit / Regional Quality Leadership teams.
  • Responsible for decision making that balances progress on global initiatives with local/R&D priorities
  • Responsible for Region / Op. Unit Quality governance (Quality Councils / Management reviews)
  • Responsible for active and timely Incident notifications and associated escalation activities

Interaction(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)

  • Key interactions with all Region / Op Unit / R&D /Quality Head and with Manufacturing and Quality regional and operating unit teams
  • Key interface with Global and Site based Quality units (as needed)
  • Responsible for supporting sites and Regional / Op. Unit / Quality leads with BOH inspection responses and timely completion of related commitments and CAPA

Innovation(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

  • A firm grasp of industry, scientific and regulatory trends, understanding market conditions and leverages innovation to evolve Takeda to become a model for industry
  • Drives innovative electronic solutions in alignment with strategic priorities

Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

  • This role reports globally but engages locally( Region / OP Unit / R&D, etc) to drive significant progress and sustainable performance of the One QMS in support of both global and local prodcuts.
  • The output of this role needs to be appropriately applied to all stages of the product lifecycle.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:(List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)

  • Scientific or engineering graduate (BSc, MSc, PhD), preferably complemented by economic education ( MBA) and IT education
  • Steadily increasing managerial experience and responsibility > 12+ years combined with strong technical operations background.
  • Experience must include successful examples of managing global change by influence – without direct resource control;
  • Experience in global pharmaceutical operations, supply chain management, Quality, project management and global environment
  • Strong focus on delivering global results as well as building site capability to demonstrate effective governance
  • Extensive global pharmaceutical industry knowledge
  • Fluent in written and spoken English.

Locations

Singapore, Singapore

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0009809

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