Associate Director, Development Program Quality Lead
Company: AveXis Inc.
Location: San Diego
Posted on: November 11, 2019
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 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 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).This candidate may describe themselves as
passionately devoted to their patients. And, if you are the kind of
person who dares to dream of something more than traditional
treatments and instead wants to be a critical part of making
transformational therapies a reality for patients who need it the
most, then this might be the right place for you.Responsibilities
- Provide leadership and quality expertise to project teams on
the development and implementation of novel quality pathways for
all aspects of the manufacturing process and method development
including starting materials, plasmids, vectors and method
qualification/validation for testing through the development
product lifecycle (preclinical and clinical studies).
- Provide strategic quality leadership on the input into the IND
of major investigational product and commercial submissions and
response to HA queries, assuring that they are complete,
scientifically accurate, of high quality and are presented in a way
that facilitates both internal and agency review.
- Evaluate program(s) providing strategic quality decisions and
documentation approvals as required.
- Evaluate and communicate risks to the development program(s)
you manage to ensure successful launch of life changing
- Ensure filing and inspection readiness from an end-to-end
product lens, and as needed, 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.
- Serve as the quality lead to support product risk assessments,
supporting the identification of quality risks and appropriate
mitigation plans to achieve compliant solutions.
- Ensure the product team's understanding of quality and
compliance standards and market specific regulations for aligned
programs, serving as the escalation lead on behalf of Quality to
guide and manage challenges to achieve risk-based solutions as
- Identify and drive continuous improvement and standard
practices for Quality to achieve both top performance and
consistency, where appropriate, across our portfolio.
- Define the stage appropriate gates required for preclinical and
clinical method development programs.
- Support the definition and requirements for development
programs. Manage site inspection preparation, management and
- Selection of manufacturing, testing, and distribution contract
suppliers (support audits as needed).
- Provide quality input during manufacturing runs, product
specifications, analytical testing and release at CMOs and internal
- Ensure all stability studies 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 10-12 years of biologics or gene therapy industry
experience in technical, quality, and/or regulatory role(s)
supporting programs in pre-clinical and clinical phase programs,
with at least one or more role (5+ years) in Quality (QA, QC).
- 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 project management skills and ability to communicate
effectively across matrix functions at all levels of the
organization, influencing areas not under direct control to achieve
shared objectives while balancing speed, quality and risk.
- Proficiency in development and execution of strategic
decisions, balancing multiple priorities in a fast-paced
environment while promoting a culture of quality and continuous
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-GK1
Keywords: AveXis Inc., San Diego , Associate Director, Development Program Quality Lead, Executive , San Diego, California
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