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Senior Solution Engineer, Quality Management Systems

Exton, Pennsylvania, Lexington, Massachusetts


Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Self-starter
  • Versatile
  • Team player

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  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Our vision is of a world with accessible healthcare for all, where prevention measures are exponentially advanced and billions are freed of disease. Our approach is rooted in our patient-centricity and the creation of outstanding treatments that change people's lives. Building upon a foundation of sustainability, we are committed to contributing to the long-term health of people through disease prevention.

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Senior Solution Engineer, Quality Management Systems

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Job ID R0012846 Date posted 10/01/2019 Location Exton, Pennsylvania; 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 a Senior Solutions Engineer, Quality Management Systems in our Lexington, MA or Exton, PA 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.

As a Senior Solutions Engineer working on the Quality Management Systems

team, you will be empowered to lead analysis, define and establish design of all technical aspects and/or provide technical expertise for IT solutions. In this role, you will contribute to Takeda’s mission by delivers system solutions and support for Quality Management System processes across the TrackWise platform. A typical day will include:


  • Leads analysis, defines and establishes design of all technical aspects or provides technical expertise for IT solutions on intermediate and large complexity IT systems and/or projects within area of expertise.
  • Maintains and uses knowledge of solutions and IT landscape to explore and identify possible solutions related to defined technical problems, and finds opportunities to improve business solutions support.
  • Maintains and partly creates elements of complex solutions.
  • Delivers system solutions and supports for Quality Management System processes across the TrackWise platform.
  • Serves as the Senior Technical SME and Administrator for QMS applications and other technologies as assigned.
  • Supports design, implementation, governance and run activities in collaboration with cross-functional business and IT areas.


  • Manages the development lifecycle of workflows across the TrackWise platform.
  • Develops and configures business workflows independently.  Evaluates user requirements.
  • Develops and implements reports and dashboards using Crystal Report, QlikSense or other equivalent tools.
  • Solves unique and complex technical problems that occur during daily operations. Acts as a point of escalation for moderate, non-routine technical problems.
  • Provides support and troubleshooting for system issues as required.  Manages resolution accordingly.
  • Develops, executes and manages technical specifications, test cases, and documentation as per Software Development Lifecycle (SDLC), Agile Scrum and Information Technology Infrastructure Library (ITIL) standards, procedures and policies.
  • Executes and supports testing, validation and maintenance of system activities.
  • Ensures proper configuration management and change controls are implemented.
  • Manages, coordinates and coaches the performance of deliverables with third party vendors, professional services, and/or consultants as per plan.
  • Maintains technical relationships with vendors in support of projects and ongoing operations.
  • Works with IT business analyst and key users to understand business needs, problems to translate to solutions and the IT landscape.
  • Develops technical roadmaps and operational plans for complex business solutions, in order to develop/improve functionality within solutions or the technical landscape. 
  • Maintains and influences technical roadmaps, ensures that operations are aligned with roadmaps and communicates status to projects.
  • Evaluates emerging technologies relevant to Quality and leads proof-of-concepts.
  • Provides continuous improvement for technology best practices and guidelines.
  • Coaches or leads lower-level Engineers and other technical groups.



  • Bachelor Degree or equivalent in Business, Computer Science, Information Systems, or equivalent education.
  • 5 years or more of relevant experience.
  • Expertise and experience in TrackWise administration, configuration (TeamAccess, WebAdmin, PR Import, Selection Import, Admin Queries, Workflows), Java web services and Crystal Reports development.
  • Technical experience in relational database management software including Oracle and MS SQL, specifically SQL querying and navigating complex data structures.
  • Knowledge of computer systems validation practices.
  • Extensive experience implementing solutions and using different Quality Systems in the pharmaceutical or Life Science Industry
  • Strong analytical and problem-solving skills.
  • Ability to write and speak in the English language.
  • Excellent oral and written communications skills, business acumen with problem solving and analytical skills.
  • Up-to-date expertise in the solution area assigned and continuously enhances own skills.
  • Is considered a subject matter expert in the technical area of expertise.


  • Master Degree.
  • TrackWise implementation experience in Pharma/Life Sciences/Medical Device companies.
  • Experience and knowledge of Agile methodology for continuous implementation.
  • Expertise and experience in QlikVi
  • ew and/or QlikSense reporting development.
  • Experience with other tracking software systems or quality management system applications is preferred.
  • Quality business process knowledge in Change Controls, Complaints, Deviations, CAPAs, Supplier Management, and Audits.
  • Understanding of IT service management processes and associated tools (e.g. ServiceNow).
  • Experience of managing third party vendors and off-shore technical teams.
  • Knowledge of Javascript and CSS scripting language preferred.


  • ITIL Intermediate level.


  • Agile (Scrum)


  • Access to transportation to attend meetings.
  • Ability to fly to meetings regionally and globally.


  • 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

Exton, PA

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0012846

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