Vacancy expired!
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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
Vacancy expired!