• Senior Manager, Quality Assurance

    Job Locations US-NC-Durham
    Posted Date 3 weeks ago(10/23/2018 2:57 PM)
    Job ID
    2018-2669
    # 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.

     

    The Senior Manager, Quality Assurance is responsible for designing and implementing robust Quality Systems for a new viral gene therapy manufacturing site. This role will be responsible for the strategic compliance quality system design and work in collaboration with Manufacturing Operations to author written procedures including but not limited to: regulatory adherence and auditing, training, raw material suppliers, supplier management, internal assessment processes, incoming release of materials and monitoring compliance with all requirements of good manufacturing practice. 

     

    The Senior Manager, Quality Assurance will provide leadership and oversight to transition a novel gene therapy into a commercially approved product. This individual must have expert knowledge and application of the CFRs and cGMPs and have been involved in regulatory inspections. 

    Responsibilities

    • Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs).
    • Responsible for leading the development and implementation of robust quality systems including:
    • SOPs/Document Management: Approve all instruction sets, specifications, instructions and other Quality Assurance procedures directly related to operations and other cGMP activities
    • Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
    • Vendor Management/Raw Material Release: Ensure all required assessment is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product
    • Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations
    • Represent AveXis in external vendor quality audit program for the manufacturing facility; manage findings, responses and corrections, lead investigations that involve any raw materials required to manufacture the product.
    • Responsible for data integrity review of electronic raw data against reported data.
    • Manage site inspection preparation, management and response process.
    • Create and maintain an internal assessment program for the manufacturing facility.
    • Establish a strong quality management review system and the assessment of its adequacy. Periodic conformance audits of the operations of the system.
    • Create monthly Quality Management Review meeting (QMR) to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.

    Qualifications

    • Bachelor’s degree in Microbiology, Chemistry or Biochemistry required.
    • Minimum of 10+ years of experience in biopharmaceutical based GMP manufacturing operations.
    • Experience with viral gene therapies and/or orphan disease indications is a plus.
    • Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
    • Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
    • Excellent oral and written communication skills with strong technical writing experience.
    • Experience leading internal audits, identifying findings, driving resolution and providing a closure report.
    • Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
    • Demonstrated long-term project planning, team building, budgeting and operational excellence experience.

     

    Approximately 20% travel required.

     

    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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