Posted to MedZilla on 12/11/2019


Takeda Pharmaceuticals

US-MA, Head of Inspection Management and Internal Audits R0011981-MZ


 
 

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use.

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:

OBJECTIVES/PURPOSE

  • 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

ACCOUNTABILITIES

  • 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

DIMENSIONS AND ASPECTS

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

Leadership

  • 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

Interaction

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

Innovation

  • 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

Complexity

  • 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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • 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

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.

No Phone Calls or Recruiters Please.

#LI-LC1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.