Manager, Quality Assurance (Exceptions Management)

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.

The Quality Assurance Manager is responsible for providing oversight of the Exceptions system at an AveXis manufacturing site. The Quality Assurance Manager will ensure the effectiveness of the Quality Systems by developing and implementing effective processes and tools for managing deviations, CAPAs, change controls, product complaints and risk assessments.

Responsibilities

• Manage the global exceptions management processes including deviations, CAPAs, change controls, product complaints, and risk assessments at a site level.
• Ensure the Exceptions systems are current, standardized, in a state of compliance, and aligned with industry best practices.
• Develop and implement a risk-based approach for triaging deviations and product complaints.
• Partner with internal customers as part of the change control review process serving as SME and/or final approver.
• Partner with customers, including manufacturing and QC to develop tools and methods to best assess nonconformances and changes.
• Evaluate investigations for appropriate product impact, patient safety, and compliance impact. In addition, review for accuracy and completeness.
• Measure, evaluate and report the effectiveness of each program.
• Develop, track, trend, and report key performance indicators (KPI) to ensure continuous quality improvements.
• Participate in the Quality Management Review and Annual Product Review reporting.
• Collaborate with the training department to identify and report issues necessitating a training remediation.
• Consult on issues that may have quality or compliance impact.
• Work with Global Quality to ensure best practices are shared with other sites.
• Assist in the definition of user requirements, selection criteria, and implementation of enterprise systems for the site GxP activities.
• Perform QA review and approvals for standard operating procedures (SOP).
• Manage function(s) supporting audits and regulatory inspections. Provide subject matter expertise during audits and regulatory inspections, as necessary.

Qualifications

• Bachelor's degree preferred.
• 10+ years of experience within a regulatory or pharmaceutical environment with a minimum of 7 years relevant experience.
• Practical knowledge of FDA, EU regulatory requirements.
• Demonstrated leadership experience that includes the ability to inspire, foster teamwork, and champion change.
• Demonstrates quality decision-making.
• Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

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.