Senior Quality Assurance Engineer
Company: AveXis Inc.
Posted on: July 13, 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 Senior
Quality Assurance (QA) Engineer will be the QA subject matter
expert for 21 CFR Part 11, data integrity, Computer System
Validation, and GAMP within the Quality Engineering team. The
candidate must have a strong working knowledge of these principles.
Responsibilities include QA approval and guidance of computer
system validation execution. The qualified candidate will partner
and work closely with the validation group to ensure a high level
of compliance. This individual must have a strong knowledge and
application of the CFRs and cGMPs and have been involved in
regulatory inspections. Responsibilities
- This person will be responsible for the Quality and Compliance
aspects of facility, equipment and automation design and work in
collaboration with Engineering, technical functions, Manufacturing
Operations and outside consultants and contractors to ensure the
AveXis facility is:
- Compliant with all appropriate regulations (e.g. FDA, EMEA and
other major health authorities) for GMP manufacturing
- Capable of manufacturing AveXis products that are safe,
effective and that meet all applied controls and
- Capable to meet intended design goals of output volume,
turnaround time and operating and product costs.
- Provide strategic quality input on the translation of
commercial product requirements into technical solutions that are
capable of meeting defined CQAs (product Critical Quality
Attributes) and CPPs (Critical Process Parameters).
- Review and approve CSV risk assessments as well as user
requirements, plans, executed protocols, procedures, and reports in
support of Computer System Validation.
- Contribute to the definition of project plan, control
requirements and processes to deliver the new manufacturing
facility on time, to required quality and compliance standards,
- Act as Quality approver of change controls and deviations.
- Contributing to design of facility, utilities and process
equipment from a Quality and Compliance perspective.
- Act as Quality approver on project deliverables, as defined in
the project plan.
- Author and/or approve Standard Operating Procedures in support
of project activity and deliverables. Qualifications
- Minimum B.S. degree in preferably engineering, chemistry, IT or
- Minimum of 5 years of experience with Computerized System
Validation (CSV), data integrity, 21 CFR Part 11, GAMP, and ALCOA
principles in a pharmaceutical GxP environment
- A minimum of 5-8 years of experience in biopharmaceutical based
GMP manufacturing operations.
- Experience with viral gene therapies, cell culture technologies
and/or orphan disease indications is a plus.
- Comprehensive knowledge of FDA and EU regulations and
experience in US and international regulatory agency
- Direct experience with commissioning, qualification and
validation to meet FDA and other health authority
- Direct experience reviewing and/or authoring standard operating
procedures and partnering with operations on change controls,
product related investigations and deviations.
- Excellent oral and written communication skills with strong
technical writing experience required.
- Experience leading internal audits, identify findings, drive
resolution and provide closure report.
- Ability to synthesize data and summarize outcomes to provide
recommendations on compliant path forward.
- Demonstrated ability to perform long-term project planning,
team building, budgeting and operational excellence.
- 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-RL1
Keywords: AveXis Inc., Denver , Senior Quality Assurance Engineer, Engineering , Longmont, Colorado
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