Senior Quality Systems Specialist

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Oct 01, 2019
Ref
2019-4212
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

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 highly motivated and solution-driven individual to join the dynamic and growing Quality Systems (QS) team at our site. The individual will collaborate closely with Manufacturing, Quality Assurance, Development, Quality Control, and Project Management teams to drive consistency in execution of non-conformances and change controls, drive continuous improvement initiatives and seek global alignments with other sites. She or he will play an active role in establishing the site QS processes to support development and commercialization of new gene therapy medicines. Responsible for driving consistency in execution of QS programs and participating in global initiatives to align QS processes at site level.

This role will work independently on problem solving, investigations, change control and implementation of preventative and corrective actions, working effectively within the group, within Quality, and across sites.

Responsibilities

  • Serve as SME for Change Control, Non-Conformance and documentation programs.
  • Provide guidance and training to site users in QS processes.
  • Create monthly QS site metrics, monitor, review and trend QS programs.
  • Lead Nonconformance and Change Control Review Board meetings.
  • Ensure all deviations and change controls are appropriately documented and investigated following QS program procedures and guidelines.
  • Review and/or author standard operating procedures and partner with operations on product related investigations and deviations.
  • Review and approve Change Control and Nonconformances.
  • Lead investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
  • Identify and implement new technologies to improve the compliance and efficiency of QS operations.
  • Participate in Site inspection preparation and response process.
  • Adhere to all GMP requirements.
  • Perform other related duties as assigned.


Qualifications

  • Minimum B.A. or B.S. in biochemistry or related scientific field.
  • Minimum of 8 years of experience in biopharmaceutical based GMP manufacturing operations.
  • Strong understanding of QS programs such as change control and nonconformance.
  • Understanding of FDA/EMEA regulations.
  • Direct experience reviewing and/or authoring standard operating procedures.
  • Excellent oral and written communication skills with strong technical writing experience required.
  • Potential for up to 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.

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