• Manager, GCP Clinical QA

    Job Locations US-IL-Bannockburn
    Posted Date 2 weeks ago(7/5/2018 3:41 PM)
    Job ID
    2018-1351
    # of Openings
    1
    Category
    Quality
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical and commercial settings 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 in the midst of an incredible journey, and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc., a Novartis Company, 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.

     

    Responsible for ensuring that clinical trial activities for assigned clinical development programs are conducted in compliance with applicable regulations, ICH Good Clinical Practice Guidelines, and internal policies and procedures. In addition, is responsible for ensuring that investigator sites, external vendors, and internal processes meet quality standards and accurately identifying and developing action plans to mitigate compliance risks. Also leads domestic and international audits of clinical investigator sites, documents, databases, vendors, and internal systems to assure compliance with applicable regulations, ICH GCP and internal procedures.

    Responsibilities

    • Develop Global QA Management Plans for assigned clinical development programs.
    • Schedule, conduct, and/or manage domestic and international audits of clinical investigator sites, documents, databases, vendors, and internal systems to ensure compliance with applicable regulations, ICH GCP and internal procedures.
    • Write and issue audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members and/or functional area management.
    • Review responses to audit findings for appropriateness and completeness. Follow up as appropriate to obtain audit response.
    • Prepare and present audit findings and/or other related information at departmental or internal operational meetings.
    • Write, review or revise Clinical QA Standard Operating Procedures (SOPs).
    • Provide Clinical QA leadership to Clinical Operation Teams.
    • Monitor compliance issues identified across clinical development programs. Analyze audit program results, quality issues and investigations to optimize global operations and overall global compliance.
    • Serve as a resource to a variety of operational departments on audit or Clinical Quality Assurance subject matter.

    Qualifications

    • Bachelor’s degree required, MPH or graduate level degree preferred.
    • 10 years of GCP related Clinical Quality Assurance experience.
    • Knowledge of applicable Global GCP regulations, Good Clinical Practices, ICH Guidelines.
    • Clinical trial audit experience is a must.
    • Self-directed and able to work effectively across multiple global cultures and with cross functional teams.
    • Excellent oral and written communication skills.
    • Strong problem solving, risk assessment and impact analysis abilities.
    • Flexible and able to multi-task and prioritize competing demands/work load.
    • Solid experience in root cause analysis/CAPA.
    • Above average negotiation and conflict management skills.

    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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