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Lead Computerized Systems Quality Assurance

Lexington, Massachusetts, Vienna, Austria

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Lead Computerized Systems Quality Assurance

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Job ID SR0043471 Date posted 11/05/2019 Location Lexington, Massachusetts; Vienna, Austria

OBJECTIVES/PURPOSE:

  • The Computer Systems Quality Assurance (CSQA) representative will provide Quality oversight for global GxP systems, applications and infrastructure associated with GxP.
  • This position will contribute to improving systems/applications quality by appropriately monitoring processes and providing recommendations for improvement opportunities for any given area of IT.
  • The position will approve validation, change control, investigation of deviation as well as provide Quality oversight and/or Quality approvals for GxP systems.
  • This position is responsible for QA oversight of the Takeda GxP related application, and established IT procedures.
  • This position will contribute to improving systems/applications quality by appropriately monitoring processes and providing recommendations for improvement opportunities for any given area of IT.

ACCOUNTABILITIES :

  • Implement and maintain global procedures for computerized systems validation
  • Drive standardization and continuous improvement activities across the global quality network
  • Providing QA oversight, review and approval of the activities related to the design, test, implementation and maintenance of IS/IT supported systems.
  • Help plan audit program and execute audits of:
    • suppliers of computerized systems, components and services
    • Takeda computerized systems, projects and processes
    • computerized systems at Takeda 's partners (e.g.CMO}, upon request
  • Monitor Quality Metrics and communicate to management to drive continuous improvement of regulated computerized systems and GXP relevant infrastructure.
  • Identifying and communicating risk in area of responsibility and across the quality network; creating strategies and plans to manage the risk to Takeda.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Minimum 5 years' experience in a Quality Assurance role related to computerized systems compliance
  • Demonstrated knowledge of predicate rules such as GLP, GMP, GCP as they relate to computerized systems
  • Experience working globally with diverse teams and cultures
  • Experience in departmental goal setting, planning and project management
  • Experience in team leadership, coaching and performance management
  • Ability to interact effectively with peers and senior management in other functions
  • Effective oral and written communication skills

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0043471

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