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 an Associate
Director, Quality Compliance & Surveillance in our Deerfield, IL office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.
As an Associate Director, Quality
Compliance & Surveillance working on the Quality
Compliance and Systems team, you will be empowered
to provide Global leadership and strategic direction across
the network. A typical day will include:
- The Associate Director,
is responsible for leading
and developing holistic
Global Complaint Processes,
including assuring site engagement and related
department support of processes.
- Strongleadership to assure compliance
timeliness of overall
Complaint Processes- especially with
regards to Regulatory reporting requirements.
- Lead development and implementation
Global Change Control
processes in addition to providing
ongoing monitoring and governance of global processes.
- Provide leadership to
define Investigation process for GxP manufacturing sites with collaboration, ongoing oversight
and governance of global
global GMP trends to help safeguard compliance
- Engage externally to assure Takeda remains current with
industry standard approaches and provide
input to design of best
practices and future regulations.
- Leadsthe development
and implementation of
customer complaint programs and processes
to establish and assure ongoing compliance and timely performance.
- Assuresglobal integration with related
disciplines R&D,Pharmacovigilance,Commercial,etc.andperform analysis
of global KPI s as relevant.
- Develop and sustain on-time
Customer Complaint performance and drive continuous improvement
(CIP) culture across all areas.
lead, and drive
sustainable change control processes that are integrated from
the product life
lead, and drive sustainability of proactive programs to ensure a
state of control
in completing thorough
and appropriate investigations.
- Stronginterpersonal andglobal
leadership skills particularly negotiation, listening,
judgment and conflict management
skills as is demonstrated in a matrix global
- Demonstratedabilityto anticipate
potential problems and risks related to global quality systems expectations
compliance with ability
to formulate action plans and implement solutions.
EDUCATION,BEHAVIORAL COMPETENCIES AND SKILLS:
- Scientificor engineering graduate (BSc, MSc, PhD) with 10 years combined
experience working with Global
combined with steadily
increasing managerial experience and responsibility.
- Leadership and solid knowledge of Global Quality Risk management with working knowledge
global investigation processes and experience implementing
Change Control systems.
- Experience in pharmaceutical
operations with product development knowledge.
- Priorleadership/management/utilization of Customer
- Directengagement with consultants/partners on Quality / Compliance related matters.
- Knowledge of ICH activities
(esp. Q8, Q9, Q10, Q11).
- Regional and International
travel are required.
WHAT TAKEDA CAN
with company match
Retirement Contribution Plan
- Tuition reimbursement
Company match of charitable contributions
- Health & Wellness
onsite flu shots and health screenings
- Generoustime off
for vacation and the option to purchase additional
- CommunityOutreach Programs Empowering Our People to
ShineLearn more at
Takedaisan EEO employer of minorities, women,
disabled, protected veterans, and considers qualified applicants with
criminal histories in
accordance with applicable laws. For more
Phone Calls or Recruiters Please.