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

• 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

• Experience in leading learning projects and/or programs for a large and diverse audience
  
  • Knowledge and experience working in a regulated environment

• 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

• Ability to make decisions on GxP/pharmaceutical activities

• 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)

• A strong understanding of industry and business, applicable legislation and regulatory compliance requirements.

• Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of products

• 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