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Senior Manager, Quality Compliance

InterMune, Inc.

Brisbane, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

?   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:
o   Ability to work with a diverse group of personalities and individuals
o   Excellent  writing skills
o   Strong verbal communication skills
•   Other Skills:
o   Ability to work independently and multitasking
o   Strong attention to detail and accuracy
o   Ability to set schedules and meet deadlines
•   Computer Skills:
o   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

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