Senior Manager, Quality Control Information Technology

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 Control IT (QCIT) Senior Manager position will be reporting to a Global function. The position is responsible for the delivery of a global platform for the planning, design, development, and implementation of quality control information systems such as LIMS, Empower, ELN, SDMS and other information systems to be compliant with regulatory requirements 21 CFR Part 11 and Annex 11. The position leads the harmonization of business processes across site into one global solution to bring consistency and standardization across sites. The incumbent works cross-functionally with internal and external departments to define and understand business requirements and translate them into technical solutions. The position assumes responsibilities for system administration activities for QC Information Systems; user accounts and access management; master data configuration for the application; changes for the application; supporting business requirements gathering; and providing daily support for the systems.

This position will also lead a group of QCIT system administrators and specialists including supervision, planning, development, and execution of tasks on projects and initiatives.

The candidate must possess strong understanding of Quality Systems in GMP environment, particularly the areas related to computerized systems and have extensive hands-on experience in computerized system development life cycle focus on system development and implementation. Must be able to work effectively within the group, within Quality, and across site.

Responsibilities

• Drive and lead the implementation of global QC information systems solutions across multiple sites (i.e. LIMS, Empower, SDMS, ELN, etc.).
• Build the development and implementation road map providing well-defined scope, timelines, and deliverables.
• Collaborate with cross-functional team, including QC, IT, QA, and Validation, to plan, design, develop, test and deploy QC Information systems.
• Work with vendors and service providers to address technical issues and provide a solution or workaround to end users.
• Provide technical support with managing and configuring master data objects for applications. Master data objects are business objects in the system configured to support business operations. (i.e. sampling plan, test methods, specifications, limits, etc.).
• Ensure master data development is in alignment with sampling plans, tests, specifications, limits, SOPs and applicable source documentations.
• Be accountable for system administrative activities for QC Information Systems; user accounts and access management; system upgrades and patch managements; master data configuration for the application; changes for the application; supporting business requirements gathering; and, providing daily support for the systems.
• Provide support for User Acceptance Testing.
• Create, maintain, review and approve system-related SOP(s).
• Review and approve system development life cycle documentations (i.e. URS, Risk Assessment, System Specifications, IOQ protocols, Reports, etc.).
• Support any system related non-conformances, CAPAs, and change control activities.
• Provide leadership and direction for a team of administrators and IT specialists.
• Responsible for selecting, developing, and managing direct reports in the most effective manner to meet assigned objectives including performance management, compensations decisions, rewarding and recognizing employees, and providing on-going, regular performance feedback.

Qualifications

• Minimum B.A. or B.S. in Scientific / Biotech / Pharmaceutical / IT, or related field
• Minimum of 5-year experience in computerized system management in GMP environment
• Minimum of 3 years of management experience with direct reports
• Experience with LIMS, Empower, SDMS, ELN and/or other laboratory information systems
• Working knowledge of GMP disciplines and regulatory requirements 21CFRPart 11 and Annex 11
• Excellent oral and written communication skills with strong technical writing experience 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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