Join us as
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:
- 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
- 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.
- Collaborate with AGILE leadership and
Global Quality leaders to align progress in Lab transformation to achieve lab
- 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
- 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
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
- Working knowledge of global Compendial
- Experience in pharmaceutical operations,
supply chain management, Quality, project management and from working in an
- Extensive global pharmaceutical industry knowledge
- Direct knowledge of USP/ EP / Compendia
- Direct engagement with consultants/partners
on Quality / Compliance related matters
- Working knowledge of ICH activities (esp.
Q8,Q9, Q10, Q11)
Regional and International Travel will be required.
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
Our People to Shine
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
No Phone Calls or Recruiters Please.