Manager, Supplier Quality Assurance

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Nov 05, 2018
Ref
2018-2394
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
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. 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 an experienced Supplier Quality Assurance (SQA) professional to join us and contribute to our SQA operations as we continue to develop and maintain supplier quality standards to ensure AveXis products are manufactured to relevant patient safety and product quality standards in line with business requirements.

Responsibilities

  • Support the Corporate Quality Assurance department responsible for delivering all aspects of the Supplier Quality Assurance function.
  • Plan, manage and support the conduct of supplier audits.
  • Manage existing suppliers in terms of periodic assessments and Quality Agreement maintenance.
  • Perform transactions for Supplier-related records and maintain data synchronization between suppliers and materials in AveXis' various internal data systems.
  • Focal point for managing supplier quality related issues and supplier-related change notifications; Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers.
  • Provide clear communication (both verbally and orally) to all levels within the organization on quality related topics.
  • Undertake root cause analyses and identify solutions for supply chain issues. Ensure corrective and preventive actions are closed out by suppliers.
  • Work with the Purchasing team on new supplier introduction and approval.
  • Work within the cross-functional team to define criteria to ensure supplier process capability is effective to meet product and process requirements measure key supplier quality performance.
  • Support the Sr. Director of the department to monitor and report on supplier product quality and performance.


Qualifications

  • 8+ years of overall working experience in Biotech/Pharmaceutical industry, with at least 3-5 years of directly supporting the Supplier Quality Assurance functions is required.
  • Hands on knowledge of quality management and business systems for managing suppliers and materials is required.
  • Strong Knowledge of GMP (US, EU and APAC) as well as ISO standards with regards to material and service providers.
  • Understanding of common biologics and sterile chemical materials manufacturing processes is strongly preferred.
  • Proven ability of planning and prioritizing activities.
  • Ability to work in a diverse and dynamic environment.
  • Ability to present data effectively.
  • Good communication and interpersonal skills.
  • Good listening and negotiation skills.
  • Good problem-solving and analytical skills.
  • Bachelor's Degree required in a scientific discipline.
  • Certification in PMP, CQA or ASQ is highly desired.
  • Ability to Travel (10%).


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.