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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- 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
- 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.
- 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)