Quality Control Information Technology Senior Specialist

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 Information Technology Specialist is responsible for Quality computerized system lifecycle management from concept, development, validation, implementation and maintenance to retirement. The incumbent will serve as subject matter expert for Quality computerized systems and ensure compliance to regulatory requirements such as 21 CFR Part 11 and Annex 11. In addition, the incumbent will be responsible for day-to-day management and continuous improvement of all QC computerized systems/processes in AveXis.

Responsibilities

• Act as administrator for Quality computerized systems such as LIMS, Empower, and lab computerized systems including Windows permissions.
• Plan and lead Quality IT projects, such as LIMS implementation and lab instrument qualification.
• Work with Quality, IT, and Validation to support Quality computerized system lifecycle management activities from concept, development, validation, implementation and maintenance to retirement.
• In addition to supporting base site, support a harmonized approach with team members across all network sites for Quality systems.
• Author and review protocols, reports, investigations, non-conformance, CAPAs, and other records related to Quality computerized systems.
• Monitor Quality computerized systems to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11.
• Assist with data integrity initiatives as they relate to Quality computerized systems.
• Lead periodic reviews of existing computerized systems and identify process improvements coordinating implementation of new processes.
• Create/maintain SOPs and training related to Quality IT systems.
• Represent Quality IT during meetings. Communicates and tracks all follow-up items through to completion.

Qualifications

• Bachelor's degree in a Scientific, Biotech, Pharmaceutical or IT field of study.
• 8+ years working in a GxP pharma or biotech environment preferred.
• 5+ years instrument administration experience preferred.
• 3+ years' experience with LIMS administration, especially STARLIMS® preferred.
• 3+ years' experience with chromatography data systems, especially Waters Empower® preferred.
• Familiarity with Windows permission settings, network domain, and a general understanding of server architecture.
• Prefer familiarity with SQL, Java, or other LIMS programming language.
• Experience should include lifecycle management of Quality computerized systems.
• Up to 10% 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. #LI-MG1