Posted to MedZilla on 6/28/2017


Takeda Pharmaceuticals

United States-, Lead Solutions Specialist, Global IT Systems - Quality 1700977-MZ


 
 

At Takeda, we work as a team to provide better health and brighter futures for all. As a global pharmaceutical company, Takeda focuses on discovering, developing and delivering innovative medicines that can have a life-changing impact for patients worldwide. In fact, patients are at the center of everything we do. We encourage our 30,000+ employees to continuously develop their skills, and we reward them for the results they achieve. We value integrity, dedication and teamwork, which are abundant in our multinational workforce. If you want to make a difference, if you want to be inspired, if you want to do important work join us.


OBJECTIVE:

  • Leads analysis and technical expertise for IT solutions on complex IT systems projects within area of expertise.
  • Defines and establishes design all technical aspect on assigned projects.
  • Using knowledge of business operations, explores and identifies possible solution needs based on defined business problems, and defines opportunities for improving related applications.


ACCOUNTABILITIES:

  • Leads a team of technical solution specialists to deliver IT solutions that allow the business to reach its strategic objectives and are implemented in a cost efficient and high quality manner
  • Defines solutions that are designed, developed and maintained in support of business.
  • Performs analysis, design and configuration of solutions according to Takeda standards for complex business requirements.
  • Oversees the capture and assignment of user enhancement requests to support one or more solutions.
  • Ensure documentation according to Takeda QMS standards, policies and procedures.
  • Contributes to detailed roadmap development of complex software or solution systems platforms working directly with the business and other IT groups
  • Owns technical relationships with vendors in support of projects and ongoing operations.
  • Ensures that solutions are designed, developed and maintained as part of structured SDLC and ITIL business process
  • Maintains up-to-date expertise in the solution area assigned and the business areas supported and continuously enhances own skills. Is considered a subject matter expert in the area of expertise.
  • Serves as lead technical SME and system administrator for quality management systems, QC laboratory information management systems (LIMS), and other technologies as assigned
  • Delivers system solutions and services across Quality business areas
  • Leads and manages the application Run activities for technologies as assigned
  • Works across business areas (i.e., GMS QA, R&D QA, Vaccines QA, Commercial QA) and in collaboration with IT area leads to support the Design, Build and Run activities
  • Identifies and troubleshoots system issues and manages resolution. Escalates issues appropriately
  • Manages validation and maintenance of systems in a validated state
  • Manages third party vendors and/or consultants to ensure deliverables are met as per plan
  • Leads monitoring and analysis of emerging technologies relevant to Quality

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:


Required:

  • 8 + years relevant experiences
  • Experience partnering with business area leaders to plan and deliver projects
  • Excellent oral and written communications skills, business acumen with problem solving and analytical skills
  • Extensive experience implementing applications
  • Ability to write and speak in the English language
    Desired:
  • Experience with the design and development of pharmaceutical life sciences software or solutions
  • Familiarity with regulated systems high level understanding of computer systems validation
    • Technical skills required: Administration for quality management systems and LIMS (e.g. TrackWise, CATSWeb, Labware), Crystal report, Relational database (e.g. SQL, Oracle), Windows server operating system
    • Best-in-company technical expertise in quality management systems and/or LIMS
    • Experience in the implementation and system administration of software applications that support QA and QC operations
    • Thorough understanding of the server and network infrastructure upon which these systems rely on
    • Thorough understanding of IT service management processes and associated tools (e.g. ServiceNow)
    • Knowledge of Javascript and CSS scripting language preferred
    • Experience in pharmaceutical industry preferred
    • Thorough knowledge of the principles of computer system validation per CFR.21 Part 11
    • Experience in system validation with SDLC methodology and/or maintenance of systems in a validated statetion

TRAVEL REQUIREMENTS:

  • Access to transportation to attend meetings
  • Ability to fly to meetings regionally and globally
*LI-SA1-EUR


Schedule
Full-time


Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.