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IT Lead Quality Management Systems

応募 後で応募 求人ID R0015895 掲載日 01/13/2020 Location:Lexington, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an IT Lead Quality Management Systems in our Lexington, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

Takeda is seeking a technology leader who will inspire new ideas, co-create solutions and drive business outcomes with data, digital and information technologies.  This individual will lead the Global Quality Management Systems IT team and will work in close partnership with Global Quality stakeholders, allied teams within Global IT, and a strong ecosystem of vendors.  This position will report to the Head of Digital Quality & EHS and will help to enable Takeda’s Global Quality function to become a leader in technology and innovation among peers in the pharmaceutical industry.

As an IT Lead Quality Management Systems working on the Quality Systems team, you will be empowered to will lead and drive business outcomes with data, digital and information technologies.  A typical day will include:


  • Shape, drive and influence digital innovation and differentiation within the Quality Management Systems domain while maintaining alignment with Global IT strategy and standards.
  • Act as a trusted advisor to the business, able to influence stakeholders at all levels toward co-creation of capabilities necessary to realize the business vision for QMS
  • Drive the design and prioritization of an investment portfolio to fully support the business vision for QMS
  • Align expectations between the business and IT with respect to IT service delivery in the QMS domain, ensuring business value realization
  • Working with the Head of Digital Quality & EHS, develop and implement a partnering strategy including operating model and talent development to enable next generation business partnering, digital leadership and service delivery.
  • Drive a risk management strategy that pro-actively addresses operational integrity, compliance, and cyber risk.


  • Provide leadership to the IT team and oversee business needs and the roadmap enabling Quality Management capabilities for Takeda globally
  • Partnering with and influence Global Quality stakeholders (leaders, process owners, SMEs) to ensure - Business alignment at strategic, tactical and operational level. Aim to prioritize the business IT requirements, investment and roadmap alignment. Maximize the value impact of technology.
  • Especially drive and shape the digital agenda with significant advancements in digital QMS technology for the respective domain.
  • Lead the development of the global QMS IT Strategy. Align QMS IT roadmap with global and local business partners and drive execution.
  • Oversee the delivery of agreed project portfolio and programs in collaboration with, peers, Global Quality stakeholders, other IT functions, and enable teams working seamlessly together. Ensure that projects and solutions are designed and delivered consistent to corporate project management framework and standards.
  • Ensure service operations (run) for global solution move into the UAMS model meet agreed expectations and service level commitments. Manage customer expectations, hold UAMS team accountable for service delivery, and develop paths of escalations across IT to ensure services impacting QMS are appropriately prioritized.
  • Drive and oversee operational excellence, simplification, new ways of working, methods (e.g. Agile, DevOps, user experience) to increase the value impact on business.
  • Develop and maintain effective working relationships with key stakeholders of strategic vendors, service providers and other external collaborators, this to improve productivity, consolidate vendors, implement a consistent location and make vs buy strategy.
  • Develop global teams towards targets, develop key talents, drive succession planning for critical roles and lead efforts in ‘being digital’. Drive synergies in collaboration between site-based teams, global teams, business.


  • Bachelor's Degree is required; Graduate degree in relevant field is desired
  • 10+ years of experience with pharmaceutical Quality Systems and associated technologies in positions of ascending responsibility
  • Experience (incl. hands-on) on large, complex IT projects from start to end
  • Highly experienced in business partnering, stakeholder management with senior business leaders around strategic planning, investments and service delivery
  • Deep knowledge of Quality Management systems and processes including but not limited to deviation, CAPA, product complaint, change control, supplier, and audit management
  • Thorough knowledge of computer-systems validation and data integrity standards as applied to QMS systems
  • Solid understanding of QMS technical architecture including key system interfaces (e.g., ERP, regulatory submission tracking, document management, QC LIMS, and data analytics/reporting)
  • Knowledge of QMS digital capability, technology trends and emerging roadmap
  • Thorough knowledge of regulations and health authority expectations regarding Quality Management Systems and computer systems validation
  • Excellent communication skills


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

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Lexington, MA

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Full time

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