Sr. Director, Supplier Quality Assurance

Job Locations US-IL-Libertyville
Posted Date 2 weeks ago(2/7/2018 3:40 PM)
Job ID
2018-1120
# of Openings
1
Category
Quality

Overview

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.

As a key member of AveXis Quality team, the Sr. Director, Supplier Quality Assurance will be responsible for the overall strategy development and execution of supplier quality management. This position will lead the design and implementation of the enterprise software solution-based supplier quality management systems, methodologies, assessment, performance management and metrics.  This position will oversee the external audit programs to meet all global regulations as related to supplier quality.

The Sr. Director, Supplier Quality Assurance will manage day to day operations including, goal setting, budgeting, hiring and development of a Supplier Quality Assurance team. This position will be a member of the Quality Leadership Team and will report to the S.V.P. of Quality and Compliance.

 

Responsibilities

  • Collaborate cross-functionally to develop and implement a highly effective supplier quality management program focused on innovative solutions to meet business challenges and deliver maximum value to the business
  • Design and implement enterprise software based solutions to operationalize the compliant processes and gain efficiencies
  • Develop and implement strategic initiatives to ensure continuous improvement with respect to supplier quality performance
  • Establish and evaluate short and long-term supplier quality goals
  • Maintain the approved supplier list and implement the use of internal quality systems resulting in successful resolution of supplier quality problems and performance issues
  • Interface with suppliers during supplier/component qualification and clinical/production phases, promoting on-going development and improvement
  • Responsible for developing audit plan and performing audits and inspection at critical suppliers

Qualifications

  • Bachelor’s Degree required in a scientific discipline
  • Master of Science degree in a scientific discipline is strongly preferred
  • A minimum of 15 years of quality management experience in the industry, ideally all clinical phases through commercial drug product.
  • Minimum of 5 years in a senior management role.
  • A strategic thinker that can break down barriers, drive great decisions, and make an impact
  • A resilient and visionary Quality Leader willing to pave a path
  • An experienced leader in Quality Management Systems and/or Quality Operations/Quality Assurance
  • Must be a visionary as well as an analytical thinker with a proven track record successfully building highly effective teams and implementing best practices
  • Experience in design and implementation of quality management solutions based on enterprise software platforms such as ACE, TrackWise, etc. is required
  • Strong knowledge of global regulations (EU, US, APAC)
  • Certification in PMP or ASQ is highly desired
  • Ability to Travel (25%)

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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