Job Description


OBJECTIVES/PURPOSE

  • Act as primary point of contact for the Quality Enterprise Systems used within TEC including but not limited to the DMS and LMS systems- to develop and maintain robust effective training content.
  • Monitor TEC quality compliance & governance performance
  • This role performs the operational quality oversight of and provides guidance to Regional Distribution Centers (RDCs) in Asia/Japan, the responsibilities cover quality aspects of warehousing, distribution and transportation as well as the management of quality and compliance issues of RDCs
ACCOUNTABILITIES Ensure compliance with:
  • Write, review and approve new or revised procedures, coordinate the gap assessment process for the TEC team
  • Build and manage the Training Curriculum requirements for the team, supported by management
  • Monitor key performance indicators, evaluates and highlights any significant trends and identifies actions prepare metrics for the Management Review of Quality Systems.
  • Coordination and execution of local Quality Council / Management Review.
  • Maintain the local quality risk register. Engage TEC stakeholders to proactively identify quality risk areas, and establish appropriate risk mitigations and risk monitoring program
  • Supports internal and external audits and regulatory inspections as needed, and maintains supportive documentation for the QMS Documentation
  • Participate in continuous improvement (Agile) initiatives and quality culture activities
  • Maintain expertise in quality systems and quality processes
  • Execute daily activities associated with implementation and maintainance of the QMS supporting activities of the trading entity team.
  • Support operational quality oversight of and provides guidance to Regional Distribution Centers (RDCs)/ Global Distribution Centres (GDCs) as required.
  • Evaluate the level of GMP/GDP compliance and risks for products managed by RDCs in the region through key performance indicators/quality performance indicators and drives the implementation of improvement activities
  • Maintain strong collaboration with Supply Chain, Site Quality Organization, RDC related LOC Quality and Takeda project teams
DIMENSIONS AND ASPECTS Technical/Functional
  • Experience in leading learning projects and/or programs for a large and diverse audience
    • Knowledge and experience working in a regulated environment
Leadership
  • Ability to lead effectively through directing change as well as driving change by influence
  • Ability to lead and engage across the globe, with both internal and external stakeholders
  • Ability to lead and implement communication, training, performance support strategies and tactics
  • Strong attention to details, ability to review & managing documentation
Decision-making and Autonomy
  • Ability to make decisions on GxP/pharmaceutical activities
Interaction
  • Key interactions with global and regional stakeholders including Supply Chain, Legal, Tax, BU’s, Quality. Strong partnerships and collaborations to ensure clear definition of requirements and com-pliance to the respective trading licenses.
  • Key interactions with numerous stakeholders in Quality (TE RP, OpU quality, Plant and Regional Quality, External Supply Quality)
Innovation
  • A strong understanding of industry and business, applicable legislation and regulatory compliance requirements.
Complexity
  • Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of products
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Critical Skills and Competencies
  • Scientific Degree (BSc, MSc)
  • 8+ years of pharmaceutical industry experience, Experience must include managing Quality Systems in a pharmaceutical or bio-technical field including DMS/LMS, QMS documentation and training, regulatory intelligence, combined with a good knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements)
  • Prior experience managing external GMP/GDP suppliers
  • Ability to demonstrate Operational Excellence/Digital and Project Management capabilities
  • Solid knowledge of Pharmaceutical manufacturing, quality, manufacturing operations, cGMPs, global regulatory or product development required
  • Excellent written and verbal communication skills and fluent in written and spoken English
  • Ability to think and act strategically and creatively
  • Ability to work successfully in multi-functional and multi-cultural teams
  • Demonstrate unquestionable integrity and professionalism
  • Customer and patient orientes mindset
  • Commitment to Takeda’s values and standards

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Job Detail

  • Job Id
    JD1117091
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Singapore, Singapore
  • Education
    Not mentioned