Posted to MedZilla on 7/23/2019


Takeda Pharmaceuticals

US-MA, Quality Control Data Systems Manager SR0036082-MZ


 
 

Primary Duties

  • The Data Systems Manager collaborates with the business and IT teams to provide support for MA Biologics Operations Site Functions.
  • The Data Systems Manager manages projects with limited supervision and is the technical lead for Analytical Instrument Qualification (AIQ) of bench top equipment and LabWare LIMS
  • The Lab Data Systems Manager is a key member of the MA Biologics Operations Quality team and ensures IT aspects related to instrument qualification meet the intended use and data integrity requirements.

The scope of work includes, but is not limited to the following:

  • Maintain and execute project and operational support initiatives across LIMS and bench top systems
  • Oversee and participate in the architectural design, development, customization and integration efforts
  • Provide oversight of vendor-provided solutions
  • Handle ad-hoc technical requests from both internal and external partners
  • Manage a team of 5-6 LIMS contractors for routine Master Data support and minor enhancements
  • Manage a team of 4-5 IT AIQ contractors including supporting PM and Validation resources

Responsibilities

70% Run the business:

  • LIMS master data for Quality and Manufacturing
  • AIQ/CSV oversight
  • Management of contract resources for LIMS, AIQ/CSV
  • Data integrity leadership

20% Change the business:

  • Continuous improvement/operational excellence support
  • Data Integrity deployment/upgrades

10% Inspection support:

  • Provide SME support during Regulatory Authority Inspections and Readiness

Education and Experience Requirements

  • Bachelor's degree in information technology, computer science, engineering, or business administration
  • Experience deploying and supporting Quality and Manufacturing Systems including Analytical and various Laboratory desktop applications used in GxP environment
  • More than 7 years relevant IT/business experience, including project scoping, analysis, and documentation of business and technical requirements
  • Experience deploying and supporting LabWare LIMS in a GMP environment (required)
  • Experience in the Pharmaceuticals or Life Sciences industry
  • Experience consulting or working in a complex, global matrix organization (preferred)
  • Knowledge of Lean operational techniques (preferred)

Key Skills, Abilities, and Competencies

IT Technology Skills & Competencies

  • IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments LIMS, Empower, Chromeleon, SOLO VPE, GE Unicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, GE DataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX, PerkinElmer Asset Genius, Thermo WebAdmin for TruScan RM Analyzer, and various Laboratory desktop applications used in GxP environment
  • Experience working with ITIL processes in ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
  • Familiarity with Operational Excellence and/or Continuous Improvement processes
  • Knowledge and familiarity of following Tools and technologies
    • MS Office 365, MS Visio, MS Project
    • Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore
    • Architectures 2 Tier, 3 Tier, On-premise, Cloud

Complexity and Problem Solving

  • Incumbent will make decisions related to project planning and execution, statement of work, and operational excellence in support of MA Biologics Operations.

Internal and External Contacts

  • Internal IT, Finance, HR, and Procurement Services
  • Customers Quality, Manufacturing, Supply Chain, and Engineering
  • External Technology vendors, providers, and innovators

Physical Demands:

  • Must be able to lift, push, pull and carry up to 10 lbs.
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

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.


Please visit our website at takedajobs.com

 
 


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