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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 developmentQA & 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 regulationsExperience in managing quality assurance in clinical research settingsQuality 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 CommunicationsQuality Service & Improvement including budgets and resource planning, collaboration with CRO on effective quality management systems and monitoringQuarterly 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 DevelopmentKnowledge 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 modalitiesKnowledge 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 QualityAbility 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 TMAPA member of the GQLT – setting the long term strategy for Global QualityFull budget accountability for this Operating UnitResponsible 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 managementA 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 DevelopmentKnowledge 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 modalitiesKnowledge 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 QualityAbility 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 TMAPA member of the GQLT – setting the long term strategy for Global QualityFull budget accountability for this Operating UnitResponsible 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 managementA 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 settingsExperience across all of the the Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) and working in an international environmentEffective finance and controlling knowledge and competencies to manage mid-large organizationFluent in written and spoken English

Core Competencies / Skills

Critical ThinkingCurrent on local and global regulationsDigital and analytical skillsInvestigation and problem solvingStrong communication skills engaging stakeholders: site, business, network, company, regulatorsRisk identification, evaluation and managementContinuous improvement

Leadership Behaviors

Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trustCreating the environment that inspires and enables peopleFocusing 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. 

For Location:

Lexington, MA

U.S. Base Salary Range:

$309,600.00 - $425,700.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time