QA Manager, Information Technology (IT) Compliance
InterMune, Inc - Brisbane, CA

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  • Must have proven experience in Part 11 compliance from a Quality prospective
  • Act as QA Project Lead for all IT programs from begin to completion
  • Conduct in-depth review of IT Change Control and Computerized Risk Assessment processes and documentation
  • Participate and direct in the creation of computer system design and implementation documents from a Quality view point to ensure Part 11 compliance
  • Author and review User Specification Requirements (URS), User Acceptance Testing (UAT), Functional Specification, IQ/OQ/PQ Protocols and Reports and Trace Matrices for accuracy, completeness and compliance to Part 11
  • Author and review IT SOPs and Work Instructions for quality and compliance oversight
  • Participate as an audit team member for QA audits of internal departments and vendor/suppliers providing computerized support and/or services


  • 8-10 years’ experience in Quality with a focus on IT Hardware & Software Implementation
  • Experience with Livelink, SmartSolve, ComplianceWire, ARISg, ComVault, SAS, VM-Ware and Sharepoint a plus
  • Strong IT technical background
  • Experience authoring SOP’s related to IT Change Control and Quality Processes
  • Strong knowledge of cGMP, GCP and ICH guidelines, Part 11 and Annex 11 for US, Canada and EU markets

Education/ Skills/ Training:

  • Communication Skills:
  • Ability to work with a diverse group of personalities and individuals
  • Excellent writing skills
  • Strong verbal communication skills
  • Other Skills:
  • Ability to work independently and multitasking
  • Strong attention to detail and accuracy
  • Ability to set schedules and meet deadlines
  • Computer Skills:
  • Knowledge of Software: MSWord, MSExcel, MSPowerpoint, MS Project, MSOutlook, Adobe Acrobat, and Visio desired
  • B.S. or M.S. in a scientific or computer engineering discipline or equivalent experience

About this company
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and...