Regional Head of Quality, Japan

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Product Quality Performance

Service & Cost Management

Compliance Management Controls

Inspection Success

Influencing Externally

Leadership/People:No. of direct reports: 10No. of indirect reports: 299Geographic Scope :Region JapanACCOUNTABILITIES

GQLT member including joint accountability for setting the strategic direction and managing performance

Japan Region Quality Team Management: Site Quality Heads, Regional Quality Systems and Compliance, Regional Quality Services and Improvement

Quality Management System for the production of API, Intermediates, Drug Product, Finished Goods and Narcotics. This includes batch review and releases, analytical reviews including stability programs and risk based deviation reviews; Quality Compliance and Systems including Change Control Management and Supplier Quality Management, Inspection Management, Metrics and KPIs, Complaints, Product Quality Communications

Quality Service & Improvement including budgets and resource planning, lab transformations and operational excellence

Japan Region Quality Performance against the KPIs

Product Quality, GMP Compliance and Inspection Readiness

Organizational Capability: readiness for technology & regulatory changes

Collaboration across GMS and GQ in the region

DIMENSIONS AND ASPECTSTechnical/Functional (Line) Expertise

Knowledge and experience of a wide range of Bio-Pharmaceutical manufacturing technologies (API,DP, Packaging; OSD, Liquids, Injectables, Lyophilization etc); with a strong focus on both small & large molecules

A firm grasp of industry, scientific and regulatory trends, estsblished products portfolio and market conditions to evolve Takeda’s regulatory profile to become the model for the industry

Leadership

Ability to lead a Quality organization, leveraging an extensive and complex network of internal manufacturing sites with full accountability for all aspects of performance (Customer Service Levels, GMP compliance, EHS compliance, Opex Cost Savings, lab transformation, People Culture & Change)

Ability to build a customer & patient-centered, best in class organization, develop diverse talent and elevate organizational performance

Ability to make Quality decisions impacting Market Actions, etc., enabling Takeda to deliver on its commitment to put patients first and build trust with society.

Decision-making and Autonomy

DOA limits to be defined in line with new TMAP

A member of the GQLT – setting the long term strategy for Global Quality

Responsible for Regional Quality Councils and resulting management actions

Responsible for taking Market Action decisions impacting on market products

Full management and P&L accountability for Quality in this Region

Interaction

Key stakeholders include: Japan Pharma Business Unit (JPBU), Supervisor General, Procurement; other internal manufacturing sites to which drug substance and drug products are transferred, Manufacturing Sciences

Innovation

Unique contribution of thought, experience, background, and skills in operational excellence and quality

Complexity

Diverse sites supplying over 50 products (API, Sterile, Solids, Narcotics and Vaccines). Several Technologies (small molecules, biologics, High-potent drug handling, anitbody drug conjugates): Products manufactured represent high sales value (3,500+ Oku Yen); Over 10 Health Authority Inspections per year including FDA, PMDA, ANVISA.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Education / Experience

Scientific degree (BSc, MSc, PhD)

15+ years of increasing management responsibility combined with strong technical operations background.

Experience across all of the the Quaility pillars (QA, QC, Systems and Compliance, Services and Improvement) and working in an international environment

Effective finance and controlling knowledge and competencies to manage mid-large organizaion

Fluent in written and spoken English

Core Competencies / Skills

Critical Thinking

Current on local and global regulations

Digital and analytical skills

Investigation and problem solving

Strong communication skills engaging stakeholders: site, business, network, company, regulators

Risk identification, evaluation and management

Continuous improvement

Leadership Behaviors

Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust

Creating the environment that inspires and enables people

Focuing on the few priorities and provide superior results

Elevating capabilities for now and the future

EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsOhio - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#LI-Remote