• Quality Information Technology Specialist

    Job Locations US-IL-Libertyville
    Posted Date 3 weeks ago(6/27/2018 11:49 AM)
    Job ID
    2018-1324
    # of Openings
    1
    Category
    Information Technology
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc. is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    The Quality Information Technology Specialist is responsible for Quality computerized system lifecycle management from concept, development, validation, implementation, maintenance, to retirement. The incumbent will serve as subject matter expert for Quality computerized systems and ensure to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11. In addition, the incumbent will be responsible for day-to-day management and continuous improvement of all computerized systems/processes in AveXis.

    Responsibilities

    • Plan and lead Quality IT projects, such as LIMS implementation and lab instrument qualification.
    • Work with Quality, IT, and Validation to perform Quality computerized system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement.
    • Perform day-to-day administration activities for Quality computerized systems, such as LIMS, ACE, and lab computerized systems.
    • Approve protocols, reports, investigations, non-conformance, CAPAs, and other records related to Quality computerized systems.
    • Monitor Quality computerized systems to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11.
    • Lead periodic review of existing computerized systems and identify process improvements and coordinating implementation of new processes.
    • Create/Maintain SOPs related to Quality IT systems.
    • Represent Quality IT during meetings, communicates, tracks all follow-up items through to completion.

    Qualifications

    • Bachelors: Scientific / Biotech / Pharmaceutical / IT field of study, preferred 6+ years Quality IT experience.
    • Experience should include lifecycle management of Quality computerized systems.

     

    The level of this position will be based on the final candidate’s qualifications.

     

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

     

    AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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