Posted to MedZilla on 10/18/2017


Takeda Pharmaceuticals

US-MA, Associate Director, Quality Risk Management 1702661-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 Associate Director, Quality Risk Management in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Associate Director working on the Quality Risk Management team, you will be empowered to influence across the organization, and a typical day will include:


POSITION OBJECTIVES:

  • Provides leadership and expertise across the R&D Quality to develop, implement and manage risk management plan & support programs. Identify and aggregate emerging risks and/or operational risks and implement related controls.
  • Partner with key stakeholders within the R&D Quality and key R&D stakeholders to direct the identification, assessment and documentation of risks and related controls associated with regulations that support R&D functions and processes.
  • In collaboration with R&D Quality Leadership, drive the identification, mitigation and implementation risk oversight, risk infrastructure development and governance.
  • Drive the development of risk policies and procedures to ensure appropriateness/adequacy and alignment with organizational/regulatory requirements and industry best practices.

POSITION ACCOUNTABILITIES:
  • Provide leadership and expertise inthe development and harmonization of risk management programs to support R&D efforts. Provide strategic and tactical leadership to support R&D risk management plans and activities.
  • Direct the formulation of risk management plans including evaluation and implementation in partnership with key business stakeholders.
  • Act as key resource and partner with risk owners on best practices as well as work with functional units in the development and implementation of risk controls to ensure compliance.
  • Provide leadership and drive strategic direction for R&D risk management programs and initiatives in alliance with R&D Quality and R&D functional units to influence process change.
  • Liaision with the functional areas across R&D to identify and mitigate risk associated with regulatory compliance.
  • Provide ongoing oversight for the risk management program.

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor s Degree in Chemistry, Biology, Engineering or related science field; Masters Degree preferred. Six-Sigma experience a plus.
  • Minimum 8 years of Quality compliance experience including implementing/managing/executing risk management programs.
  • Must have good working knowledge and understanding of the drug development lifecycle and processes to manage risk and ensure regulatory compliance as well as good understand of ICH Q8, Q9, Q10 guidelines.
  • Deep understanding of risk management principles to support a flexible and ever-changing regulatory landscape.
  • Experience in identifying and implementing risk management initiatives with excellent organizational and communication skills.
  • Demonstrated ability to anticipate, formulate, and implement solutions related to risk mitigation and compliance.
  • Highly analytical, with the ability to analyze a wide variety of information and make decisions regarding potential risks associated with compliance.
  • Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.
  • Strong interpersonal skills particularly in conflict management skills, demonstrated by ability to lead and implement complex, programs in a highly matrixed organization.
  • In-depth understanding of regulations governing the US and international pharmaceutical industries. Ability to translate and articulate appropriate strategies and activities to ensure compliance relative to quality risk management principles.

PHYSICAL DEMANDS:

  • Routine demands of an office-based environment

TRAVEL REQUIREMENTS:

  • Approximately 10-15% domestic and international travel.

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.

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Schedule

Please visit our website at takedajobs.com

 
 


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