Associate Director, Quality Assurance, Development Testing
Company: AveXis Inc.
Location: San Diego
Posted on: January 17, 2020
OverviewReady 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
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
- 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
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