Posted to MedZilla on 11/14/2019

Takeda Pharmaceuticals

US-MA, Leader of Quality Management Systems (QMS) Architecture R0012443-MZ


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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 Leader QMS Architecture in our Greater Boston area offices.

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 Future to people around the world.

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


Accountable for establishing, integrating, and continuously improving the Quality Management System through the Quality Manual, Global Quality Standards and Global SOPs. Partners with Quality Process owners and Operating units to ensure consistent deployments of Quality Standards and Global SOPs through an effective and efficient Quality Management System. Maintain Global standards and procedures aligned with regulatory expectations and industry best practices.


  • Responsible for Quality Policy, Global Standards and Global Procedures Lifecycle
  • Ensure Global Quality Standards and SOPs are deployed consistently throughout the global organization
  • Lead gap analysis teams and implementation planning for standards as required.
  • Work directly with Quality Process owners, Compliance Leads and Operating units for standard deployment and revision as needed.
  • Responsible for integrating acquisitions into the Quality Standards and Global Procedures.
  • Maintain Global standards and procedures aligned with regulatory expectations and industry best practices
  • Works closely with the rest of the Quality Management team to ensure streamlined compliant solutions are used throughout the organization.
  • Other duties as required.
  • Strong leadership and effective interpersonal skills particularly motivational, negotiation, listening, judgement and conflict management skills as is demonstrated in a matrix global environment.
  • Demonstrated ability to act globally to anticipate potential problems and risks related to quality systems expectations. Esperience with organizational change management.
  • Proven leadership capability and effectiveness in ability to work well with cross-functional teams to accomplish objectives.
  • Demonstrated leadership and capability to work effectively in a fast paced rapid changing technology environment and to work on multiple work streams and projects simultaneously
  • Excellent organization, written, and verbal skills to convey global project goals and inspire support from both subordinates and senior management


  • Scientific or engineering graduate (BSc, MSc, PhD)
  • Minimum of 10 years experience with CGMP and Compliance
  • Experience must include successful examples of QMS architecture management including managing global change by influence without direct resource control;
  • Strong focus on delivering global results as well as building site capability to demonstrate effective governance
  • Extensive global pharmaceutical industry knowledge
  • Fluent in written and spoken English.


  • 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

Discover more at

No Phone Calls or Recruiters Please.


Boston, MA

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Full time

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