Associate Director, Quality Assurance, Development Testing
Company: AveXis Inc.
Location: San Diego
Posted on: May 26, 2019
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
- 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
- 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
- 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.
- 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
- 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
- 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
Didn't find what you're looking for? Search again!