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Program Manager, Inspection Management - United States  

Company managed [?] Still accepting applications

Posted on : 22 December 2017

Project Description

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 Program Manager, Inspection Management in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.  As a Program Manager, Inspection Management working on the R&D Quality Assurance team, you will be empowered to provide support to manage regulatory inspection activities in R&D, and a typical day will include:

POSITION OBJECTIVES:
  • Work with inspection readiness team members from the functional groups in R&D and R&D Quality to prepare for and support of regulatory inspections
  • Communicate closely across multiple functional groups in R&D and R&D Quality to make sure that regulatory commitments from regulatory inspections are completed timely and appropriately
POSITION ACCOUNTABILITIES:
  • Facilitates inspection readiness activities to prepare for regulatory authority inspections working with the team members from the functional groups in R&D and R&D Quality
  • Provide training sessions for the inspection readiness team for their preparedness
  • Support regulatory authority inspections as an active participant in the Staging Room and lead pre-inspection preparation activities including facilitation of regulatory readiness meetings, managing and maintaining logistics including roles and responsibility listings, contact lists, and creation/consolidation of documentation
  • Communicates closely across multiple functional groups in R&D and R&D Quality to make sure that regulatory commitments are completed timely and appropriately
  • Identify and implement process improvement initiatives that enhance the process robustness for inspection management

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:  

  • Bachelor’s Degree in Chemistry, Biology, Engineering or related field; Masters preferred
  • Minimum of 5 years of Quality/QC/Compliance experience
  • In-depth understanding of global regulations governing the US and international pharmaceutical industries
  • Ability to translate and articulate appropriate strategies and activities to ensure compliance to all regulations relative to quality management systems
  • Ability to communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing
  • Ability to demonstrate professional presentation skills and deliver informative and balanced presentations and, when applicable, facilitate resolution of differing opinions
  • Demonstrated analytical capabilities with the ability to analyze a variety of information and data for the process improvements regarding potential risks associated with regulatory compliance
  • Demonstrated ability to anticipate potential problems and risks related to quality system expectations and regulatory compliance, formulate action plans, and implement solutions
  • Must have an advanced knowledge and understanding of the drug development process, scientific methods and thought processes, specifically the manufacturing process, to ensure regulatory compliance information is up-to-date

TRAVEL REQUIREMENTS:

  • Approximately 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
Full-time