Posted to MedZilla on 1/21/2018

Takeda Pharmaceuticals

US-MA, Senior Manager, R&D Quality Systems and Compliance - Quality Performance Management 1800130-MZ


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 Senior Manager, R&D Quality Systems and Compliance - Quality Performance Management in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager working on the R&D Quality team, you will be empowered to lead metrics reporting and analysis, and a typical day will include:


Provide R&D Quality Leadership and strategic project management across function

  • Lead and maintain overall R&D Quality metrics reporting processes in alignment with the Global Quality organization.
  • Lead and engage across R&D Quality to drive consistent reporting practices
  • Drive processes to assure timely and accurate updates of R&D Quality metrics
  • Lead logistics to support R&D Quality Council processes; escalation processes from R&D Quality groups
  • Track overall R&D Quality performance and assure consistency of data reported and communicated
  • Develop and sustain R&D Quality competent authority metric reporting processes in collaboration across functions
  • Develop and lead monitoring and management process for external events and trends in collaboration with R&D Quality Leadership
  • Drive processes to ensure efficiency, collaboration and operational excellence in the R&D Quality organization
  • Lead and provide a role model for Takeda-ism and Leadership behavior


  • Work independently to drive R&D Quality monthly highlight and metric processes
  • Drive R&D Quality data collection and necessary supporting processes to sustain all R&D Quality KPI's
  • Assure preparations, create content and deliver materials for R&D Quality Councils
  • Deliver routine communications regarding metrics with R&D Quality LT
  • Lead R&D Quality monthly/quarterly/annual reporting processes in alignment with GQO
  • Lead and routinely demonstrate strong interpersonal skills including motivational, listening, judgment and conflict management skills as demonstrated in a matrix global environment
  • Through analysis, tracking and trending of metrics data, anticipate potential problems and risks related to quality systems and regulatory compliance with ability to formulate action plans and implement solutions
  • Lead and drive collaborations with cross-functional team to accomplish objectives
  • Ability to work independently in a fast paced, rapid changing technology environment and to work on multiple projects and work streams simultaneously
  • Excellent organization, written and verbal skills to convey R&D Quality project goals and inspire support


Knowledge and Experience:

  • Bachelor s degree required. An advanced degree preferred.
  • Minimum 8 years experience working in a pharmaceutical or health related industries
  • Cross functional global experience in Pharmaceutical Operations, Quality and Project Management involving international operations
  • Broad knowledge base in global Quality practices and Regulatory Agency regulations
  • Demonstrated experience in leading global change by influence
  • Strong focus on delivering global results as well as services
  • Proven experience working remotely to support R&D Quality governance and capability processes across global networks (R&D Quality Councils and related processes)
  • Experience working with remote Quality leadership and demonstrated flexibility to provide global support and services (work remotely and travel to support sites if necessary)
  • Proven experience in working across global quality roles and with manufacturing and development sites to implement effective processes and governance
  • Knowledge of Global Quality Governance processes external to R&D Quality and ability to drive best practices integration to internal processes
  • Leadership and solid working knowledge of R&D Quality Systems, change control processes, R&D Quality procedures/documents and ability to drive "best practices" via influence
  • Previous experience supporting global multi-cultural Quality management
  • Independent leadership and program management skills
Skills and Competencies:
  • Strong understanding of the pharmaceutical industry with focus on development
  • Proven experience in pharmaceutical development support and governance
  • Proven business knowledge and negotiation skills
  • Structured approach to communication and presentation to senior management
  • Global outlook bringing in trends and developments for decision making
  • Knowledge and experience in pharmaceutical technology
  • Knowledge and experience in development supply chain management
  • Knowledge and experience in analysis of metrics data
  • Knowledge and experience in project management
  • Knowledge and experience with Quality Management and systems in a regulated industry
  • Patient and customer centric with service orientation
  • Experienced leader, motivating and building trust
  • Strong drive and focus on results
  • Experienced in coaching and developing staff
  • Successful in building relationships and teamwork
  • Experienced in managing intercultural teams
  • Experienced in negotiating and resolving problems
  • Good communicator
  • Driver of change and effective in team building


  • 15-20% travel is required for this position


  • 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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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit

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