Associate Director, Supplier Quality Management

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.

The Senior Manager, Supplier Quality Management (SQM) is responsible for the overall program management and will work cross-functionally to execute and improve SQM programs that support AveXis' commercial expansion and rapidly growing clinical pipeline products.

Responsibilities

• Provide leadership for the management and improvement of the SQM Program.
• Direct the management and enhancement of a phase-appropriate supplier qualification and Specification development processes that will use risk-based tools for qualification, classification and monitoring.
• Provide direction to team as Quality SME for supplier issues and discrepancies, and lead/manage the investigations to resolve the issues as warranted for significant matters.
• Collaborate with Supply Chain, Manufacturing Science & Technology, Site Manufacturing and Regulatory Affairs to define and execute a process to support a growing supplier network including 2nd-sourcing raw materials and global emerging suppliers.
• Collaborate cross-functionally and with the suppliers to improve partnerships and prepare for future growth.
• Lead, develop and manage a high performing, collaborative team of SQM team members throughout multiple sites to execute the following:
  • Assure execution of the supplier-initiated change notification process is timely for processing of change impacts and coordination with Supply Chain to manage any inventory impacts.
  • Assure Supplier maintenance and periodic monitoring cycles are adhered to.
  • Assure Quality Agreements are developed with high quality and periodic review cycles are adhered to.
  • Assure adherence to audit schedule, management of audit closure for suppliers of raw materials and GxP services, and maintenance of the approved supplier list.
  • Develop, assess and report on supplier performance metrics to executive management (e.g. QMRs).
• Lead and support the business requirement development, configuration, testing and user approval efforts pertaining to SQM-related electronic system enhancement projects.
• Support inspection readiness plans and present program during regulatory inspections as SME.

Qualifications

• Minimum B.S. degree, preferably in microbiology, chemistry or biochemistry.
• Minimum of 10 years of experience in a pharmaceutical or biologics supplier quality management role; biologics or vaccines experience preferred.
• Minimum of 5 years of direct supervisory experience of technical professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff.
• ASQ Certified Quality Auditor preferred.
• Comprehensive knowledge of FDA and EMA regulations and experience in interaction with US and international regulatory agency inspections is required.
• Experiences in auditing suppliers for raw materials, primary and secondary packaging components, contract labs, CMO sites, service providers and warehouses are required.
• Experience managing CMOs, CTLs, third party logistics, transportation couriers, cold chain logistics and contracted GxP services providers are required.
• Experience in identifying, writing, evaluating and closing investigations is required.
• Excellent oral and written communication skills with strong technical writing experience. required.
• Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
• Domestic and international travel required (15%)

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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