Head of Quality, Research and Development

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Job Description

OBJECTIVES/PURPOSE

• A key member of the R&D Extended Leadership Team, this function provides quality and compliance oversight for functions reporting into R&D CMSO and Vaccine Development, including Research, Global Development Operations, Global Patient Safety Evaluation / Global Vaccines Safety Evaluation, Global Medical Affairs, Global Regulatory Affairs, Pharmaceutical Sciences, Statistical and Quantitative Sciences, and Therapeutic Area Units.  The key focus on preventing quality issues that could impact our ability to deliver safe and effective treatments and vaccines to patients.

• A key member of the Global Quality Leadership Team, the role holder will be required to set the longer-term strategy and plans for the function, establish priorities, build a global patient-centered best in class organization, develop diverse talent and elevate organizational performance, and manage the overall finances of this function.

ACCOUNTABILITIES

• Establish Quality Management System for R&D and Vaccines development
• QA & QC for all R&D programs, working closely with the R&D function to cover: Research Quality, Investigational Medicinal Product (IMP), Clinical QA, Pharmacovigilence (PV)/ drug safety QA and LOC Medical Quality. 
• Deep Understanding of clinical trial processes and regulations
• Experience in managing quality assurance in clinical research settings
• Quality by Design ensuring a systematic approach to development this is  based on sound science and quality risk management.
• 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, collaboration with CRO on effective quality management systems and monitoring
• Quarterly quality reviews of strategic CROs and collaboration with R&D to improve efficiency/KPI’s of CROs

Technical/Functional (Line) Expertise

• Knowledge and experience of Bio-Pharmaceutical Research and Development
• Knowledge and understanding of all therapeutic areas as well as scientific advances and modalities for treating diseases.
• Knowledge and understanding of relevant regulations enabling effective partnership with R&D for all modalities
• Knowledge of Takeda strategy and business performance and using that information to anticipate long range planning  

Leadership

• Ability to lead a global Quality Unit, covering Takeda’s entire pipeline as well as LOC Medical Quality
• Ability to build a customer & patient-centered best in class organization, develop diverse talent and elevate organizational performance.
• Ability to operate cross functionally, partnering with stakeholders such as the DDU, Clinical Development, Medical Affairs, Regulatory, Pharmaceutical Sciences, Vaccines BU, Quality Compliance and Systems

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
• Full budget accountability for this Operating Unit
• Responsible for R&D Quality Councils, Notifications to Management and decisions impacting the progress of research and clinical trials

Interaction

• Key Stakeholders include: the DDU, Clinical Development, Medical Affairs, Regulatory, Pharmaceutical Sciences, Vaccines BU, Quality Compliance and Systems

Innovation

• Unique contribution of thought, experience, background, and skills in Quality by Design ensuring a systematic approach to development that takes into consideration the objectives and emphasizes product and process understanding and process control, and is based on sound science and quality risk management
• A firm grasp of industry, scientific and regulatory trends, understands market conditions, and develops strategies to evolve Takeda’s regulatory profile to become the model for the industry.

Technical/Functional (Line) Expertise

• Knowledge and experience of Bio-Pharmaceutical Research and Development
• Knowledge and understanding of all therapeutic areas as well as scientific advances and modalities for treating diseases.
• Knowledge and understanding of relevant regulations enabling effective partnership with R&D for all modalities
• Knowledge of Takeda strategy and business performance and using that information to anticipate long range planning  

Leadership

• Ability to lead a global Quality Unit, covering Takeda’s entire pipeline as well as LOC Medical Quality
• Ability to build a customer & patient-centered best in class organization, develop diverse talent and elevate organizational performance.
• Ability to operate cross functionally, partnering with stakeholders such as the DDU, Clinical Development, Medical Affairs, Regulatory, Pharmaceutical Sciences, Vaccines BU, Quality Compliance and Systems

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
• Full budget accountability for this Operating Unit
• Responsible for R&D Quality Councils, Notifications to Management and decisions impacting the progress of research and clinical trials

Interaction

• Key Stakeholders include: the DDU, Clinical Development, Medical Affairs, Regulatory, Pharmaceutical Sciences, Vaccines BU, Quality Compliance and Systems

Innovation

• Unique contribution of thought, experience, background, and skills in Quality by Design ensuring a systematic approach to development that takes into consideration the objectives and emphasizes product and process understanding and process control, and is based on sound science and quality risk management
• A firm grasp of industry, scientific and regulatory trends, understands market conditions, and develops strategies to evolve Takeda’s regulatory profile to become the model for the industry.

Complexity

• This role is responsible for Quality for Takeda’s entire pipeline as well as LOC Medical Quality.  It covers all R&D programs across all therapeutic areas: Research Quality, Investigational Medicinal Product (IMP), Clinical QA, Pharmacovigilence (PV)/ drug safety QA and LOC Medical Quality

Education / experience

• Scientific degree (BSc, MSc, PhD)
• 15+ years of increasing management responsibility combined with Research and Development  background with a deep understanding of managing quality assurance in clinical research settings
• Experience across all of the the Quality 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 organization
• 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
• Focusing on the few priorities and provide superior results

Elevating capabilities for now and the future

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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EEO Statement

Takeda 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.

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