Posted to MedZilla on 10/18/2017


Takeda Pharmaceuticals

US-IL, Assoc Dir, Quality Compliance & Surveillance 1702363-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 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:

POSITIONOBJECTIVES:

  • The Associate Director, Quality Compliance and Surveillance is responsible for leading and developing holistic Global Complaint Processes, including assuring site engagement and related department support of processes.
  • Strongleadership to assure compliance and sustainable timeliness of overall Complaint Processes- especially with regards to Regulatory reporting requirements.
  • Lead development and implementation of 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 processes.
  • Monitor global GMP trends to help safeguard compliance in plants.
  • Engage externally to assure Takeda remains current with industry standard approaches and provide input to design of best practices and future regulations.

POSITIONACCOUNTABILITIES:

  • 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.
  • Create, lead, and drive sustainable change control processes that are integrated from development through the product life cycle.
  • Create, 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 environment.
  • Demonstratedabilityto anticipate potential problems and risks related to global quality systems expectations and regulatory 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 Complaint programs combined with steadily increasing managerial experience and responsibility.
  • Leadership and solid knowledge of Global Quality Risk management with working knowledge of global investigation processes and experience implementing Change Control systems.
  • Experience in pharmaceutical operations with product development knowledge.
  • Priorleadership/management/utilization of Customer Complaint process.
  • Directengagement with consultants/partners on Quality / Compliance related matters.
  • Knowledge of ICH activities (esp. Q8, Q9, Q10, Q11).

TRAVEL REQUIREMENTS:

  • Regional and International travel are 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
  • Generoustime off for vacation and the option to purchase additional vacation days
  • CommunityOutreach Programs Empowering Our People to ShineLearn more at takedajobs.com.

Takedaisan EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://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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