Posted to MedZilla on 10/17/2017


Takeda Pharmaceuticals

US-MA, Associate Director, Quality Compliance and Lab Excellence 1702303-MZ


 
 

Join us as an Associate Director, Quality Compliance and Lab Excellence in our Boston office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Quality Compliance and Lab Excellence working on the Quality team, you will be empowered to provide Global Leadership and execution across the network. A typical day will include:


POSITION OBJECTIVES:
  • The Associate Director, Quality Compliance and Lab Excellence contributes to Takeda s mission through providing leadership and execution, driving sustainable change in routine laboratory performance consistent with program AGILE goals and timelines.
  • Leading and sustaining a programmatic approach across the network and with global sites to assure ongoing compliance with external compendia/monographs.
  • Provide networking and management of internal and external resources to drive continuous improvement in QC laboratory performance.
  • Align external resources and site plans to achieve seamless integration of planned lab excellence initiatives.
  • Provide strong leadership to assure alignment with ongoing AGILE programs across global network of sites.
  • Support documentation updates and procedural changes at the global document level in LEADS.
  • Monitor global GMP trends to help safeguard compliance in plants (no major recall, no warning letters).
  • Engage and monitor global external landscape utilizing technical expertise to assure compliance with external Regulatory and Quality Compliance trends and events.
POSITION ACCOUNTABILITIES:
  • Collaborate with AGILE leadership and Global Quality leaders to align progress in Lab transformation to achieve lab excellence.
  • Monitor timelines to assure progress consistent with global plans and targeted improvements.
  • Assures global integration across regions to drive sustainable progress in lab performance
  • Responsible for defining and supporting ongoing sustainable global process review and updates of Compendial Change process.
  • Manage the development, implementation, and analysis of Global KPI s as relevant.
  • Drive continuous improvement (CI) culture across all areas.
  • Develop expertise to interpret and convert data from global external observations, commitments, and escalation issues into action items for systemic improvements, especially with regard to overall laboratory operations.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Scientific or engineering graduate (BSc, MSc, PhD), preferably Chemistry or Engineering
  • Steadily increasing managerial experience and responsibility 10 years combined with strong technical operations background.
  • Working knowledge of global Compendial Processes
  • Experience in pharmaceutical operations, supply chain management, Quality, project management and from working in an international environment
  • Extensive global pharmaceutical industry knowledge
  • Direct knowledge of USP/ EP / Compendia processes
  • Direct engagement with consultants/partners on Quality / Compliance related matters
  • Working knowledge of ICH activities (esp. Q8,Q9, Q10, Q11)

TRAVEL REQUIREMENTS:

Regional and International Travel will be required.

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.


Schedule


Please visit our website at takedajobs.com

 
 


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