Posted to MedZilla on 12/11/2019

Takeda Pharmaceuticals

US-MA, Head of Inspection Management and Internal Audits R0011981-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 Head of Inspection Management and Internal Audits in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Head working on the R&D Quality team, you will be empowered to oversee the inspection management and internal audit program across R&D (GLP/GCP/GVP/GMP for IMP/Device), and a typical day will include:


  • Partners with R&D and R&D Quality stakeholders to oversee and provide a strategy in the preparation for and management of inspections and development and delivery of responses and regulatory commitments
  • Ensures that an efficient and effective framework is in place to support and manage inspections and internal audits across R&D


  • Directs and manages a team responsible for internal audits and inspection-related activities including readiness, logistics, reporting and follow up
  • Maintains the R&D inspection management framework which includes a standardized process across R&D GxPs, an inspection readiness training and lessons learned programs and other tools (e.g., Audit Utopia)
  • Determines and implements best practices improvements identified through lessons learned, customer and stakeholder feedback, inspection-related KPIs/metrics, etc.
  • Develops and executes a risk-based mock inspection program
  • Develops and executes a risk-based strategic and tactical internal audit plan across R&D GxPs
  • Reports on inspection trends, risks and mitigation plans to R&D Quality senior management
  • Engages and collaborate with R&D stakeholders to ensure adequate oversight of Takeda R&D inspection landscape


Technical/Functional (Line) Expertise

  • Knowledge and experience of Bio-Pharmaceutical Research, Development, and Manufacturing
  • Knowledge and understanding of relevant regulations enabling effective partnerships across the network
  • Knowledge and understanding of global and local Quality and Regulatory concepts, requirements (e.g. ICH, Annex 1, Compendia, etc.) and trends
  • Knowledge and understanding of risk management


  • Ability to lead effectively through directing change as well as driving change by influence
  • Ability to lead and engage in complex investigations and propose sound, scientific, and compliant resolutions
  • Ability to lead and engage across the globe understanding local regulatory and cultural nuance

Decision-making and Autonomy

  • An active member of R&D Quality
  • Responsible for active and timely risk reporting and associated escalation activities


  • Key interactions with all global R&D
  • Responsible for supporting regulatory inspection responses and timely completion of related commitments and CAPA


  • A firm grasp of industry, scientific and regulatory trends, understanding market conditions and leverages innovation to evolve Takeda to become a model for industry
  • Drives innovative electronic solutions in alignment with strategic priorities


  • This role supports multi-GxP (GLP/GCP/GVP/GMP) activities across R&D and requires working knowledge and experience of international regulatory requirements (e.g., EMA, FDA, MHRA, PMDA, etc)
  • This role may also require engagement on inspections for key LOCs


  • BS/BA degree required; Advanced degree preferred in pharmaceutical, medical or engineering (MSc, PhD)
  • Minimum 12 years of industry experience steadily increasing managerial responsibility and matrix leadership in combination with strong technical operations background.
  • Experience must include 8+ years of regulatory inspection experience in GxP, GCP and GVP preferred and 5+ years management experience preferred
  • Knowledge and experience preparing and managing regulatory authority inspections with GCP, GLP, and GPV preferred
  • Direct interaction with inspectors preferred
  • Strong focus on delivering global results as well as building site capability to demonstrate effective governance
  • Extensive global pharmaceutical industry knowledge
  • Demonstrated ability to interface with senior leaders and cross-functional teams
  • Excellent written and verbal communication skills and fluent in written and spoken English
  • Demonstrated ability to effectively manage multiple priorities with a sense of urgency


  • 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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