Director, Global Quality Risk Management

Employer
AveXis Inc.
Location
Durham | US-CO-Longmont | US-IL-Libertyville, NC, US
Posted
Sep 25, 2019
Ref
2019-4241
Discipline
Quality, Quality Control
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 Director, Global Quality Risk Management (QRM) to serve as the global process owner of the end to end Global Quality Risk Management System across AveXis sites, including drug substance and drug product clinical and commercial production for viral gene therapy products. This role will also act as the owner of the Global Quality Management Review process, working with senior stakeholders such as site heads and senior Quality leaders to ensure that the Global Quality Management Review process functions effectively. The Director, Global QRM will have oversight of the Quality Risk Management Governance process globally, ensure compliance with global regulations and standards for QRM, own the risk register for Quality Operations, and manage of the AveXis Management Review process and Quality Key Performance Indicators. The Director, Global QRM provides direction and support to other departments and project teams in meeting quality and business objectives as they relate to GxP risk management, ensuring that AveXis meets its strategic and tactical quality goals.

Responsibilities

  • Establish, create and maintain an integrated risk register for Global Quality. Own and operate the process for Quality Risk Management, ensuring that risk management is integrated with AveXis quality strategy and activity.
  • Implement and manage the global AveXis Management Review process and Quality Key Performance Indicators.
  • Provide leadership to the Global Quality Risk Management program. Manage and continually improve QRM system supporting AveXis sites.
  • Formulate risk management strategies, principles, methods and tools, and document in appropriate AveXis policies, procedures, and reports.
  • Educate and train staff (across sites) in quality risk management principles and practices and act as a subject matter expert and resource for QRM matters.
  • Support data driven risk assessments including risk identification, analysis and ranking.
  • Responsible to develop and manage data analysis and statistical tools used to support quality risk management activities.
  • Oversee QRM program to ensure risk assessments are conducted as required and manage the overall process, tasks, and communications.
  • Communicate the outcome from quality risk management activities to all key stakeholders.
  • Provide ongoing collaboration, engagement, and education to cross-functional AveXis functions in the application and compliance of risk assessment and mitigation processes.
  • Work with the AveXis leadership to integrate quality risk management concepts and philosophies into the overall Quality System.


Qualifications

  • Minimum B.S. degree in science related field; higher level degree (MS, MBA) preferred but not required.
  • 8-10 years' experience in manufacturing, quality, and contract supplier/customer interactions with progressively expanding leadership roles.
  • Strong project management, budget, and presentation skills.
  • Previous experience in Quality Risk Management is preferred.
  • Knowledge and understanding of cGMPs.


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.