• Associate Director, Global Safety Quality Compliance & Training

    Job Locations US-IL-Bannockburn
    Posted Date 4 days ago(6/14/2018 3:38 PM)
    Job ID
    2018-1302
    # of Openings
    1
    Category
    Global Patient Safety
  • 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., 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 Global Patient Safety (GPS) Quality, Compliance & Training Associate Director is responsible for supporting the GPS Quality & Compliance activities based on relevant regulations, procedures, and contractual requirements. Through implementation of quality and compliance tracking tools, oversight strategy and relationship management, this role will support the management of all GPS SOPs, CAPAs and inspection related activities, as well as leading a QC system for Safety Database, Querry tools and all GPS documents. The GPS Q&C Associate Director will manage a global GPS training program, including the implementation, tracking, maintenance, and effectiveness checking of all GPS training activities. The incumbent will support the organization and maintenance of a GPS compliance system with metrics.

     

    This individual should be a self-starter with excellent leadership and management capabilities who is seeking to be part of an innovative and fast-paced team to support the company’s drug development activities.

    Responsibilities

    • Lead AveXis GPS process improvements including authoring controlled procedures, maintaining the GPS procedures Index, leading meetings of subject matter experts to revise procedures and merge procedures, to reduce the total number of procedures for improved efficiency.
    • Lead the development and implementation of the global GPS training strategy (training matrix development, process, content, delivery, system, tracking, metrics)
    • Lead AveXis’s GPS quality system, which includes supporting the management of all GPS SOPs, CAPAs, and inspection related activities, as well as a QC system for all GPS documents
    • Manage Pharmacovigilance Agreements creation and revision. Maintain the GPS project tracking tool for quality and compliance oversight.
    • Develop and manage a quality system for GPS documents including ICSRs, PSUR, DSURs, ad hoc reports, compliance and performance metrics, alliance management and signal management activities.
    • Responsible for the development, effectiveness evaluations, and compliance with GPS SOPs. Where there is cross-reference and/or cross functionality with other controlled procedures, ensure GPS SOP alignment.
    • Serve as the primary point of contact for GPS during audits and inspections.
    • Monitor global pharmacovigilance regulatory intelligence to determine impact on AveXis’s pharmacovigilance quality system.
    • Manage PV commitments from internal audits, regulatory inspection findings, and CAPAs.
    • Contribute to the PV System Master File (PSMF) to ensure it is maintained on a regular basis.
    • Manage the collection, organization, and presentation of all required global GPS compliance metrics including vendor and partner oversight metrics.
    • Develop methods to determine the effectiveness of GPS training and initiate improvements as required
    • Represent GPS training on cross-functional learning initiatives and partner with related departments (Learning & Development, IT, Commercial Training, etc.) accordingly
    • Remain current with global pharmacovigilance regulations and requirements, evaluate legislative changes affecting GPS, and develop strategies to support the patient safety at the local level

    Qualifications

    • Bachelor’s Degree or equivalent work experience in a scientific or technical discipline
    • Must have a minimum of 5+ years of experience in pharmacovigilance. Experience in areas of GXP regulations with 3-5+ years of experience in a quality and compliance role within pharmacovigilance highly preferred.

    Competencies:

    • Quality and compliance background, preferably related to Pharmacovigilance
    • Demonstrated analytical and process skills and the ability to apply these skills to AveXis’s PV organization
    • Effective communication, consulting, customer service and problem-solving skills
    • Must be detail oriented, capability to meet deadlines
    • PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required)
    • Excellent time and project management skills
    • Strong interpersonal skills and ability to interact with all levels of the organization and cross-culturally
    • Strategic planning exposure
    • Build positive relationships with regulators, inter and intradepartmental customers, internal and external stakeholders
    • Analyze and interpret regulations and laws and apply to current and future AveXis’s policies and procedures (may include collaboration with other cross functional areas)
    • Global mindset required
    • Demonstrated ability to influence others

    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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