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Job Description

OBJECTIVES/PURPOSE

A key member of the Global Quality Leadership Team (GQLT). With responsibility for Quality across 5 manufacturing sites, this role provides leadership and strategic direction to ensure the quality assurance and dispositioning of API, Drug Product and Finished goods from the operations within the region. The role includes responsibility for Quality in a complex manufacturing operation (API, ADC, solids, steriles, high-potency) and above site functions.

This is a transformation role, requiring strong leadership to continue to deliver against the Quality Vision and Roadmap. This includes:

• Product Quality Performance
• Service & Cost Management
• Compliance Management Controls
• Inspection Success
• Influencing Externally

Leadership/People:

No. of direct reports: 10
No. of indirect reports: 299

Geographic Scope:

Region Japan

ACCOUNTABILITIES

• 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 ASPECTS

Technical/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