Quality Systems Specialist

Durham, NC, US
Aug 22, 2019
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

Ready 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.

AveXis is seeking a Quality Systems Specialists responsible for designing and implementing robust Quality Systems for an AveXis gene therapy manufacturing site, considering global and local requirements of the company. This role will contribute significantly to the execution of these systems, will author or contribute to the procedures governing these systems and will work towards timely implementation, providing expertise and participate in the management of health authority inspections.


  • Provide strategic quality input on the design and architecture of AveXis' Quality System.
  • Responsible for developing robust quality systems, including both implementation and operation at site level, including:
    • SOPs/Document Management: approve site manufacturing documents, instruction sets, specifications, Standard Operating Procedures (SOP's) and other Quality Assurance documents directly related to operations and other cGMP activities
    • Deviation Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
    • CAPA review and processing: Ensure CAPA's are written and executed according to existing procedures and applicable regulations providing value added input to scope, content and target dates
    • Change Control,
  • Provide assurance of data integrity through review of paper and electronic raw data .
  • Contribute significantly to the site inspection preparation, management and response process
  • Support quality management review and assessment including periodic conformance audits of the operation of site QMS.
  • Represent Quality Assurance on project teams and in meetings.
  • Support the continuous improvement and oversight of Quality Management System procedures.


  • Minimum Bachelor's degree preferably in Biology, Microbiology, Chemistry Biochemistry or Engineering.
  • A minimum of 2 years of experience in bio-pharmaceutical based GMP manufacturing operations.
  • Ability to apply a phase appropriate, risk-based approach to QA operational decisions.
  • Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
  • Has reviewed, assisted in the investigation of, and approve environmental excursions.
  • Experience working in a GMP manufacturing environment.
  • Well versed in cGMP/ICH/FDA/EU regulations and guidelines.
  • Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint).
  • Experience with viral gene therapies and/or orphan disease indications is a plus.
  • Excellent knowledge of FDA and EU regulations with experience in US and international regulatory agency inspections a plus.
  • Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
  • Excellent oral and written communication skills with strong technical writing experience 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.