Manager, Supplier Quality Assurance (SQA)

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 an experienced Supplier Quality Management 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

To Support the Supplier Quality function within the department, responsible for delivering all aspects of the Supplier Quality Management global functions:

• Focal point (for Colorado site) for managing supplier quality related issues and supplier-related change notifications; Facilitate the escalation of unresolved supplier/material quality issues within assigned projects and suppliers
• 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
• Provide clear communication (both verbally and orally) to all levels within the organization on quality related topics
• Effectively evaluate materials, components, and services provided by AveXis suppliers in terms of quality, regulatory, and business risk.
• 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 Associate Director of the department to monitor and report on supplier product quality and performance

Qualifications

• Bachelor's Degree required in a scientific discipline
• 6+ years of overall working experience in Biotech/Pharmaceutical industry, with at least 3 years of directly supporting the Supplier Quality Assurance functions is required
• Understanding of common biologics and sterile chemical materials manufacturing processes is strongly preferred
• 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
• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
• Ability to work in a diverse and dynamic environment
• Willingness to think outside of the box and adapt best practices to the growing environment
• Good communication and interpersonal skills
• 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.

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