SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Associate Director, Quality Assurance, Development Testing

Company: AveXis Inc.
Location: San Diego
Posted on: May 26, 2019

Job Description:

OverviewReady 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 (ZOLGENSMA--). 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 Associate Director is responsible for preclinical and clinical Quality Assurance (QA) activities that drive the IND engine at AveXis, for novel viral gene therapies. This person will be responsible for decision-making regarding all quality assurance topics and for collaboration with core team members of AveXis to ensure quality and compliance for the product candidate(s) managed. A successful candidate will provide critical strategic quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a strong knowledge and application of the CFRs, and international regulations and have been involved in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international). Responsibilities

  • In a global function, collaborate with Analytical and Development groups to support method qualification, validation and transfer activities, as well as comparability as required throughout product lifecycle.
  • Assure documentation associated with R&D, vendors, and QC are complete, scientifically accurate, of high quality and are presented in a way that facilitates both internal and agency review for the development programs. The focus should be sound testing strategies (phase appropriate), on using repeatable/reproducible methods in a compliant manner.
  • Perform documentation review and approvals for the Quality Assurance role including technical transfer protocol, evaluation of product specifications, methods, review and approval.
  • Evaluate and communicate risks to the development programs managed (phase appropriate) to ensure successful launch.
  • Ensure filing and inspection readiness and support both site readiness and any applicable interactions with regulatory agencies.
  • Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies.
  • Ensure the product team's understanding of quality and compliance standards for GLP and GCP testing requirements and market specific regulations for your programs, knowing when and how to effectively escalate issues to the IND Engine and senior leadership.
  • Identify and drive continuous improvement and standard practices for Quality to achieve both top performance and consistency, across our portfolio.
  • Support the definition and requirements for development programs. Manage site inspection preparation, management and response process.
  • Selection of testing sites and support audits as needed.
  • Provide quality input on product specifications and methods at CMOs and AveXis sites.
  • Review all stability studies and ensure they are designed and executed to enable IND and eventual commercialization. Qualifications
    • Bachelors' and/or Masters'/PhD degree in scientific discipline with a technical understanding of biopharmaceutical production and/or understanding of cell or gene therapy and drug product development and manufacturing and testing.
    • Minimum of 5-8+ years of biologics or gene therapy industry experience in technical (e.g. method development, transfer), quality, and/or regulatory role supporting programs in pre-clinical and clinical phase programs, with at least one or more role (5+ years) in Quality (QA, QC, R&D QA).
    • Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
    • Direct experience reviewing and/or authoring IND/BLA sections of regulatory filings and partnering with operations on product related investigations and deviations.
    • Strong communication skills at all levels of the company, and skills in influencing areas not under direct control to achieve shared objectives while balancing speed, quality and risk.
    • Proficiency in balancing multiple priorities in a fast-paced environment while continuously promoting a culture of quality and improvement.
    • 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. #LI-JH1

Keywords: AveXis Inc., San Diego , Associate Director, Quality Assurance, Development Testing, Executive , San Diego, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Encinitas Project Management/PMP Tutor Jobs
Description: Encinitas Project Management Tutor Jobs Varsity Tutors has students in Encinitas looking for Project Management tutoring. Varsity Tutors is a live learning platform that connects
Company: Varsity Tutors
Location: Encinitas
Posted on: 06/25/2019

Outside Sales/Route Sales Manager - Full Training
Description: Sales job title: Outside Sales/Route Sales Manager - Full TrainingBuild a Great Career and a Great Life.Sales job title: Outside Sales/Route Sales Manager - Full TrainingFeel the freedom independence (more...)
Company: Mac Tools
Location: Encinitas
Posted on: 06/25/2019

Senior Director, Corporate Development #06SD
Description: Senior Director, Corporate Development San Diego,
Company: Ansun BioPharma, Inc.
Location: San Diego
Posted on: 06/25/2019


JDHuntr Attorney Law Jobs 27998 Government Relations Manager/Affairs, San Diego, CA
Description: JDHuntr Attorney Law Jobs 27998 Government Relations Manager/Affairs, San Diego, CA To apply go to JDHuntr.com must
Company: JDHuntr In-House Counsel Jobs
Location: Encinitas
Posted on: 06/25/2019

Project Director
Description: Kitchell Contractors, Inc. is seeking an experienced OSHPD Healthcare Project Director in San Diego, CA to contribute to the growth and success of our Southern California healthcare portfolio. This employee-owner (more...)
Company: Kitchell Corporation
Location: San Diego
Posted on: 06/25/2019

Outside Sales/Route Sales Manager - Full Training
Description: Sales job title: Outside Sales/Route Sales Manager - Full TrainingBuild a Great Career and a Great Life.Sales job title: Outside Sales/Route Sales Manager - Full TrainingFeel the freedom independence (more...)
Company: Mac Tools
Location: Carlsbad
Posted on: 06/25/2019

Shift Manager
Description: Like the bottom bun of a burger, Five Guys offers a solid foundation At Five Guys, we serve outstanding burgers and fries, in clean restaurants with a top tiered customer service approach If you can lead, (more...)
Company: Five Guys Enterprises LLC
Location: San Diego
Posted on: 06/25/2019

Chula Vista Project Management/PMP Tutor Jobs
Description: Chula Vista Project Management Tutor Jobs Varsity Tutors has students in Chula Vista looking for Project Management tutoring. Varsity Tutors is a live learning platform that connects
Company: Varsity Tutors
Location: Chula Vista
Posted on: 06/25/2019

Internal Communications & Events Manager - San Diego
Description: Our HR team is comprised of experts in employee relations, organizational development, payroll, benefits, wellness programming and talent acquisition. As a team, we strive to advocate for our employees, (more...)
Company: GreatCall
Location: San Diego
Posted on: 06/25/2019

Director of Business Development, Biopharma Partnering (REMO
Description: Epic Science's Director of Business Development, BioPharma Partnering will report to the Sr. Director, Corporate Commercial Development and will be responsible for developing and expanding strategic account (more...)
Company: Epic Sciences
Location: San Diego
Posted on: 06/25/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds