Sr. Manager, Quality IT

Job Locations US-CA-San Diego
Posted Date 1 week ago(3/14/2018 3:50 PM)
Job ID
# of Openings


Ready to join a team committed to moving gene therapies into the clinical setting for patients and families devastated by rare neurological genetic diseases?  AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101.  We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.


AveXis, Inc. is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.


The Quality IT Sr Manager is responsible for Quality computerized system lifecycle management from concept, development, validation, implementation, maintenance, to retirement. The incumbent will serve as subject matter expert for Quality computerized systems and ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11. In addition, the incumbent will be responsible for day-to-day management and continuous improvement of all computerized systems/processes in AveXis.


The candidate should possess strong understanding of Quality Systems in GMP environment, particularly the areas related to computerized systems. She or he should have extensive hands-on experience in computerized system validation (CSV). She or he should be able to work effectively within the group, within Quality, and across site.


  • Independently plan and lead complex Quality IT projects, such as LIMS implementation and lab instrument qualification
  • Work with Quality, IT, and Validation, Quality Control, and Manufacturing to perform Quality computerized system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement
  • Perform day-to-day administration activities for Quality computerized systems, such as LIMS, ACE, and lab computerized systems
  • Approve protocols, reports, change controls, non-conformance, CAPAs, and other records related to Quality computerized systems
  • Monitor Quality computerized systems to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11
  • Serves as a subject matter expert for Quality computerized systems and routinely engage regulatory agencies during inspections related to computerized systems
  • Lead periodic review of existing computerized systems and identify process improvements and coordinating implementation of new processes
  • Facilitate training of new and existing users for Quality computerized systems
  • Create/Maintain SOPs related to Quality computerized systems
  • Represent Quality IT during meetings, communicates, tracks all action items through to completion
  • Support investigations to determine root cause of deviations and implement appropriate corrective and preventative actions in a timely manner
  • May supervise Quality IT specialists and analysts


  • Minimum B.A. or B.S. in Scientific / Biotech / Pharmaceutical / IT, or related field
  • Minimum of 8-year experience in computerized system lifecycle management in GMP environment
  • 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.


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