Sage Therapeutics

  • IT Validation, Consultant

    Job Locations US-MA-Cambridge
    Posted Date 1 month ago(11/12/2018 8:59 AM)
    ID
    2018-2378
    # of Openings
    1
    Category
    Information Technology
  • Overview

    SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for providing Quality Assurance (QA) oversight and approval of computerized system validation activities which include periodic reviews, audits and inspections of a variety of GxP software systems.

     

    Responsibilities

    • Develop enterprise documentation for IT including GxP processes, Validation deliverables, IT governance policies & procedures
    • Primary: Act as Validation lead for GxP computer systems
    • Secondary: Act as BA for system implementations when required
    • Develop/Author & Lead Validation package documentation such as Validation Plan, UAT scripts, TM etc
    • Lead collaborative review and approval of documents
    • Collaborate closely with cross-functional teams that includes QA, Business Sponsor, IT infrastructure and Management to ensure consistent and correct documentation

    Qualifications

    • Bachelors Degree in Science, Technology or Management with 5+ years of experience as in Parma/Life sciences with specific systems experience in implementing Quality and Regulatory systems   
    • Strong Validation skills with at least 3+ years of experience as a CSV lead
    • Strong Facilitation skills to develop consensus and clarity
    • Ability to learn new ways and innovate
    • Strong BA skills
    • Ability to respond to fast changing requirements & deliver quickly and to collaborate with a diverse cross functional team
    • Preferred : experience with ARIM and VEEVA systems
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
    • Excitement about the vision and mission of Sage

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