Manager, Quality Assurance and Compliance

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 Manager, Quality Assurance and Compliance to provide critical quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have expert knowledge and application of the CFRs and cGMPs and have been involved in regulatory inspections. The Compliance Manager is responsible for making quality decisions and addressing or resolving issues based on experience, written procedures and analytical analysis. They are also responsible for the oversight of regulatory audits, complaints, annual product quality review, and quality management review.

Responsibilities

• Responsible for supporting the development and implementation of robust compliance and quality systems including:
• Inspection readiness, regulated inspection hosting, and response
• SOPs/Document Management: Approve all instruction sets, specifications, instructions and other Quality Assurance procedures directly related to operations and other cGMP activities
• Deviation/CAPA Management approval: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Requires direct input on the creation and effectiveness of Corrective and Preventive Action plans. Assist with implementation and supporting on-going continuous improvements.
• Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations.
• Manage site inspection preparation, inspection logistics and execution, and response process.
• Manage the monthly Quality Management Review meeting (QMR) to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
• Support oversight of testing operations in the QC laboratory, as needed, including but not limited to data integrity review of electronic raw data against reported data.
• Review and approval of QC test data, as needed.
• Create and maintain an internal assessment program for the QC Lab.

Qualifications

• Minimum B.S. degree; life sciences background or emphasis preferred
• Minimum of 8+ years of experience in biopharmaceutical based GMP manufacturing operations
• Strongly prefer skills in inspection readiness, regulated inspections, response and CAPA writing.
• Experience with viral gene therapies and/or orphan disease indications is a plus.
• Previous experience with management of teams and processes is preferred.
• Comprehensive knowledge of FDA and EU regulations and direct experience in US and international regulatory agency inspections.
• Direct experience reviewing and/or authoring standard operating procedures and review and approval of investigations and deviations.
• Excellent oral and written communication skills with strong technical writing experience.
• Experience supporting audits, identifying findings, driving resolution and providing a closure report.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
• Must have strong knowledge and application of the CFRs and 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. #LI-MG1