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Director -Quality

応募 後で応募 求人ID R0009809 掲載日 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

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