Posted to MedZilla on 4/22/2018

Takeda Pharmaceuticals

US-MA, Program Manager, Inspection Management R0000299-MZ


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Job 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:

  • 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


  • 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


  • 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


  • Approximately 15% domestic and international travel


  • 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

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Cambridge, MA

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Full time

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