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Regulatory Intelligence, Senior Quality Assurance Specialist

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Job ID R0048055 Date posted Sep. 20, 2021 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?

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.

OBJECTIVES/PURPOSE

  • Support and Responsible for implementation of integrated and sustainable Regulatory Intelligence strategies, processes, and activities for Takeda’s products (clincial and commerical) enabling a sustainable existence on the market
  • Execute collaborative process with Global Quality and Global Manufacturing Suppy functions and other Takeda Business functions and stakeholders to execute Regulatory Intelligence (RI) strategies including but not limited to integrated processes for all OpUs and Regions, R&D processes, Governance Forums, and support due dilligence evaluations for RI for the integration of Takeda acquisitions
  • Drive progress on cross functional projects related to Regulatory Intelligence

ACCOUNTABILITIES

  • Responsible for execution of design and sustainability of overall Regulatory Intelligence strategies and processes for Takeda
  • Support day to day operations of Regulatory Intelligence for Takeda and communication of any trends or concerns to in-line management.
  • Strong and effective interpersonal skills particularly motivational, negotiation, listening, judgement and conflict management skills as is demonstrated in a matrix global environment.
  • Excellence in interpreting RI compliance trends which may impact Takeda’s business operations globally with ability to formulate action plans and implement solutions
  • Demonstrated ability to act globally to anticipate potential problems and risks related to regulatory compliance expectations
  • Proven ability to work well with cross-functional teams, especially GMSGQ, R&D, and QA Systems teams, to accomplish objectives.
  • Ability 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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Scientific or engineering graduate (BSc, MSc, PhD), preferably complemented by economic education ( MBA)
  • Steadily increasing managerial experience and responsibility > 5 + years combined with strong technical operations background.
  • Experience must include successful examples of managing global change by influence – without direct resource control;
  • Strong focus on delivering global results as well as building capability to demonstrate effective governance
  • Fluent in written and spoken English.
  • Strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk based recommendations.

This job posting excludes CO applicants.

#GMSGQ

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
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