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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 SummaryWe 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:300,800.00 - 413,600.00The 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-termincentives. 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.
LocationsLexington, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job ExemptYes