Posted to MedZilla on 1/22/2018


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:


POSITION OBJECTIVES:

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

POSITION ACCOUNTABILITIES:

  • 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

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

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:
Functional
  • 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
Technical
  • 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
Behavioural/Interpersonal
  • 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

TRAVEL REQUIREMENTS:

  • 15-20% travel is required for this position

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.

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 http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

#LI-LC1


Schedule
Full-time

Please visit our website at takedajobs.com

 
 


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