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 RDCsACCOUNTABILITIESEnsure 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 teamsDIMENSIONS AND ASPECTSTechnical/Functional Experience in leading learning projects and/or programs for a large and diverse audience. Knowledge and experience working in a regulated environmentLeadership 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 documentationDecision-making and Autonomy Ability to make decisions on GxP/pharmaceutical activitiesInteraction 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 productsEDUCATION, 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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