Quality Systems Specialist

Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings 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 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , 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.

AveXis is seeking a Quality Systems Specialist responsible for designing and implementing robust Quality Systems for an AveXis gene therapy manufacturing site, considering global regulatory 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.

Responsibilities

• Provide strategic quality input on the design and architecture of AveXis' Quality Management System.
• Responsible for the development and oversight of robust quality systems, including both implementation and operation at site level, including:
  • Document Management: approve site manufacturing documents, work instructions, specifications, Standard Operating Procedures (SOP's) and other quality-controlled documents directly related to operations and other cGMP activities. Review includes ensuring alignment with applicable regulations.
  • Exceptions and CAPA management: Ensure all nonconformances, including product complaints, are appropriately documented and investigated to determine root cause and remediated effectively within the CAPA system per procedure.
  • Change Control review and approval
• 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 assessments including periodic compliance audits of the site QMS.
• Represent Quality Assurance on project teams and in meetings.
• Facilitate the use of a risk-based approach for decision-making within the QMS. In addition, properly escalate high quality risks per procedure.
• Monitor and report key performance indicators as appropriate.
• Support the continuous improvement and oversight of Quality Management System program.

Qualifications

• Minimum of a Bachelor's degree, preferably in a Life Sciences field.
• A minimum of 3 years of relevant experience.
• 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, nonconformances, change controls, and CAPAs.
• Experience performing exception investigations, including root cause analysis.
• Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in US and international regulatory agency inspections a plus.
• Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint).
• Experience with viral gene therapies and/or orphan disease indications a plus.
• Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
• Ability to work well independently and within a team.
• 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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