• Director, Manufacturing Quality Assurance

    Job Locations US-NC-Durham
    Posted Date 1 week ago(6/18/2019 1:39 PM)
    Job ID
    2019-3117
    # of Openings
    1
    Category
    Quality
  • Overview

    Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

     

    AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    The Director, Manufacturing Quality Assurance is responsible for designing and implementing innovative and robust processes for Quality review and release activities associated with a viral gene therapy manufacturing site which includes bulk product and sterile fill operations. This person will be responsible for developing the strategy for overall site quality operations including but not limited to: on-the-floor QA review activities which support a multi-shift manufacturing schedule, collaborating with Manufacturing operations to authorize written procedures such as: pre and post approval of batch production records, raw material/component specifications, facility related SOPs, calibration/maintenance documentation, consumable and raw material release. In addition, this individual will oversee and manage overall batch release activities to support a multi-product, multi-phase manufacturing scope and will bring a phase appropriate approach to the execution of quality oversight. This position will lead product quality reviews for the site and act as the primary liaison for QP related release needs.

    Responsibilities

    • Develop and deliver robust procedures and processes for efficient oversight and release of GMP consumables, disposables, raw materials, bulk drug product and finished vials.
    • Act as a critical thought leader for site GMP operations and workflows.
    • Create risk based, compliance and business aligned strategies for phase appropriate batch release operations.
    • 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).
    • Recruit and manage a high performing, collaborative team of QA operations professionals to support quality operation activities including:
      • SOP/Document Management: Approve all instruction sets, specifications, sampling instructions, test methods etc. and other quality control procedures directly related to operations and other cGMP activities.
      • In collaboration with the Quality Systems team, ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address root cause.
      • Component/Disposable/Raw Material Release: Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for disposables, 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.
    • Be a primary participant in site inspection preparation, management and response process.
    • Oversight and approval of site QC related activities: EM, release data, stability, sterile operations review.
    • Provide strategic input on quality related business systems such as change control, deviation/CAPA, maintenance/calibration, and work orders and contribute to specifications and user requirements as well as assisting with the implementation and supporting on-going improvements.
    • May lead the quality review of Quality Control function (QA for QC) tasked with QA oversight and support of overall facility QC related activities including environmental monitoring data review, QC lab equipment and method qualifications, QC batch release data, CofA review and approval.

    Qualifications

    • Minimum B.S. degree, preferably in microbiology, chemistry or biochemistry.
    • 10-15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product preferred. Experience with viral gene therapies and/or orphan disease indications is a plus.
    • 7+ years of direct supervisory experience of technical professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff.
    • Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
    • Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product/facility related investigations and deviations.
    • Excellent oral and written communication skills with strong technical writing experience required.
    • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
    • Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
    • Strong knowledge and application of the CFRs and cGMPs and have been involved in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international).

     

    Approximately 10% 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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