Associate Director, Quality Assurance - Clinical Product Release

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.

This position will be responsible for performing release activities for clinical QA activities in support of internal and external GMP activities for cell therapy products. The candidate is expected to provide leadership for maintaining and enhancing, in a phase-appropriate manner, the quality and compliance culture.

This candidate may describe themselves as passionately devoted to their patients. And, if you are the kind of person who dares to dream of something more than traditional treatments and instead wants to be a vital part of making transformational therapies a reality for patients who need it the most, then this might be the right place for you.

Responsibilities

• Generation and issuance of specific phase appropriate batch release procedures.
• Manage batch release activities for clinical production including but not limited to review of batch records, analytical data with emphasis on the effect of safety and/or efficacy impact to the clinical study, certificates of analysis, evaluation of the IND and other documents.
• Provide direction for complex deviations and CAPAs in support of batch release as well as understanding the specific impact on preclinical and clinical studies.
• Provide status reports, including relevant quality metrics and participate in the management review process.
• Partner with Supply Chain, Clinical Operations, Product Development departments and CMOs to identify and implement GxP procedures in compliance with regulations/guidelines.
• Periodically conduct audits to ensure that systems are operated in accordance with established SOPs and GMPs.
• Support preparation for regulatory agency inspections and participate as a Subject Matter Expert during regulatory GMP inspections.
• Provide quality assurance leadership, support, guidance and direction to internal manufacturing and external quality teams operating under phase appropriate cGMP regulations.
• Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
• Actively manages department and site goals and objectives.
• Perform other duties as assigned.

Qualifications

• B.S. or advanced degree in chemistry, microbiology or related science
• Minimum 6-8 years of experience in the gene therapy / biopharmaceutical industry and 2-3 years direct experience managing preclinical and clinical quality release activities.
• Good knowledge of biologics cGMP manufacturing including ideally recombinant protein and cell therapy cGMP manufacturing.
• Proven management skills with ability to work with high performing teams, and lead others effectively.
• Experience with cGMP manufacturing of clinical trial material.
• Audit and investigation skills.
• Good verbal, written, and interpersonal communication skills.
• Proficiency in Microsoft Office applications.
• Ability to operate in a fast-paced, multi-disciplinary environment.
• Approximately 20% travel required.

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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