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Manager of IT Validation CoE – ERP Products

応募 後で応募 求人ID R0013210 掲載日 10/24/2019 Location:Zurich, Switzerland

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Job Description

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us!

OBJECTIVES: 

  • Responsible for the development, execution and review of relevant system Validation and SDLC deliverables of computerized systems for the Validation Center of Excellence – ERP Products.
  • Manage budgets and business plans, as appropriate. 
  • Manage a group of employees, vendors, consultants and/or contractors responsible for ERP Products Validation services

ACCOUNTABILITIES: 

  • Design and implement the ERP Products Validation CoE strategy, in alignment with the Global IT Validation CoE strategy
  • Define, develop and implement process/procedures related to management and operations of the IT Validation CoE - ERP Products.
  • Delivery of IT Validation support to IT projects and maintenance of IT Systems, in particular, not limited to the ERP Products space
  • Develop and maintain the relevant Project support/cost/budget including monthly reviews, forecasts and allocations. This includes managing Validation resource budget, as applicable.
  • Manage a group of Validation/SDLC Leads/consultants who test, evaluate, and validate IT systems and identify issues in software or services.
  • Manage the hiring and performance of the IT Validation/SDLC staff within area of responsibility, and guide the development of individual staff members to insure appropriate skills and behaviors exist to accomplish function goals.
  • Define, execute and monitor quality metrics related to ERP Products -Validation CoE, and lead continuous process improvement activities.
  • Partner with IT management, PMO and project managers from ERP Products to;
  • ensure corporate/local quality standards and policies are applied consistently across all IT projects.
  • plan, prioritize and schedule the resourcing of projects and services including the use of alternative resourcing models such as Offshore.
  • Represent Takeda during FDA or other regulatory agency inspections involving computer validation, electronic record/electronic signature, data integrity, and overall IT Systems Validation.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  

  • Bachelor’s degree and ten years IS/IT experience, or, High School diploma and twelve years IS/IT experience.
  • Minimum of two years people management experience.
  • Have in depth knowledge of and stays current on the System Life Cycle (SLC) methodologies, IT compliance and computer system validation.
  • Familiar with a variety of the pharmaceutical industry’s concepts, practices, and procedures and how they are best applied to ERP Products.
  • Good understanding of SAP products and related validation strategies.  
  • Ability to lead teams in the correct interpretation of regulations
  • Demonstrated the ability to make quality decisions that will set precedence for systems development.
  • Good oral and written communications skills, business acumen with problem solving and analytical skills
  • Ability to write and speak the English language
  • Experience with Agile development and project methodologies, preferable.

LICENSES/CERTIFICATIONS:

Desired:

  • American Society for Quality (ASQ)
    • Certified Software Quality Engineer (CSQE)
    • Certified Quality Auditor (CQA)
  • Quality Assurance Institute (QAI)
    • Certified Quality Auditor (CQA)
    • Certified Software Test Engineer (CSTE)

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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