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Senior Quality Assurance Engineer

Company: AveXis Inc.
Location: Longmont
Posted on: July 13, 2019

Job Description:

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 specifications
    • 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, within budget.
    • 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 biochemistry.
      • 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 inspections.
      • Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
      • 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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