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Director of Quality Systems Pe...

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Job Summary

Company
Takeda
Location
Boston, MA
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4314_R0003315

Director of Quality Systems Performance

About the Job

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as a Director of Quality Systems Performance in our Cambridge office.

 

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director of Quality Systems Performance working on the R&D Quality team, you will be empowered to develop, implement, and manage strategies and processes to improve quality and promote compliance with health authority requirements and Takeda’s expectations, and a typical day will include: 

Objectives

  • This position leads the objective evaluation of R&D Quality Systems performance and provides guidance for implementation of improvements and corrective & preventive actions for related processes.
  • This role is responsible for implementation and management of a robust Quality metrics reporting process in alignment with the Global Quality organization.
  • The Director of Quality Systems Performance ensures that data-driven performance management and quality improvement programs are designed and implemented in a manner that aligns with the organization’s overall strategy.

Accountabilities

  • Provide strategic leadership to a group of professionals responsible for collaborating with stakeholders in R&D and Quality to develop, track, analyze and report key performance metrics that support quality, compliance, and GxP objectives.
  • Develop and communicate the strategic vision, scope and mission of the Quality Systems Performance group.
  • Provide leadership across the R&D organization through the organization and conduct of Quality Council review meetings.
  • Oversee the compliance and administration of R&D’s Deviation/Investigation/CAPA management processes, ensuring timely closure and effectiveness.
  • Build collaborative relationships with relevant functions in R&D to ensure alignment of strategy and to fulfill responsibilities to the organization.
  • Serve as a key leader within the broader R&D Quality organization by developing and leading improvement initiatives which support the Quality and R&D organizations.
  • Partner with and influence key personnel in Takeda’s Global Quality Organization and R&D Quality to align and facilitate harmonization of strategy, procedures, and processes.
  • Provide subject matter expertise as the leader of Quality Systems Performance during applicable regulatory inspections of Takeda R&D activities, presenting to and interacting with inspectors as necessary.
  • Additional duties as assigned.

Education, Competencies & Skills

  • Bachelor’s Degree required.  Advanced degree preferred
  • Minimum of 12 years of increasing responsibility and experience in the global pharmaceutical industry. 
  • Minimum of 7 years of managerial experience
  • Minimum of 10 years of Quality or Compliance experience.
  • In-depth understanding of international regulations governing the pharmaceutical industry.
  • Experience working within a complex organization and demonstrated ability to work across functions and regions, at all levels where the incumbent may not have direct authority.
  • Expert knowledge and experience with data analysis, reporting and trending.
  • Proven success in identifying and implementing organization-wide operational excellence/improvement initiatives.
  • Ability to influence and work effectively with various business partnerships, regions and cultures.
  • Strong interpersonal skills particularly motivational, negotiation, listening, judgment, and conflict management skills, demonstrated by ability to lead teams in a complex, matrixed and global environment.
  • Excellent organization, verbal and written communication skills.
  • Demonstrated ability to work well with cross-functional teams to accomplish objectives.
  • Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.

WHAT TAKEDA CAN OFFER YOU:

  • 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

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
 

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