Senior Director, Data Integrity Officer, Global Quality

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.

Drives and supports site level implementation of behavioral culture change and business process improvements to enhance Data Integrity (DI) controls within the AveXis Network, in conjunction with Technical Operations, Clinical Operations, IT, QC, Research, and other platform functions. Monitors progress against the Data Integrity Plan, oversees implementation of corrective and preventive measures (CAPAs), drives the escalation and investigation process for DI issues at clustered sites in proper direction, and delivers coaching and training to sites within the cluster to achieve a consistent and compliant state of DI control.

Responsibilities

• Lead the drive to change human behaviors and culture relevant to ensuring Data Integrity (DI) across the AveXis network, including indirect management of site DI Leads and other SMEs through site visits, community calls and other mechanisms and alignment with NTO and AveXis and DI site staff.
• Represent AveXis QA within the Global Data Integrity steering group. Identifies and escalates pertinent issues for the cluster, reports on progress of initiatives, and collaborates across clusters to achieve global goals for the DI program.
• Ensure the implementation of effective business processes, procedures and practices in alignment with regulatory expectations and company policies for DI through its lifecycle, including GxP computer systems, hybrid systems and manual/paper systems.
• Assure global and other metrics are effectively in place to follow progress and effectiveness of the DI Plan in a holistic way, and provide periodic status/progress updates to management, reacting to any identified issues or trends in an effective and timely manner.
• Hire site DI staff to support sites with maintaining and measuring DI performance and controls.
• Partner with stakeholders to drive significant DI deviation investigations at sites to appropriate closure.
• Conduct business reviews at sites to assure progress against DI objectives.
• Support audit and inspections of key DI related topics, for internal organizations and external parties at both the global and site level.
• Coordinate and drive a network of SMEs for sharing best practices aimed at sustainability of data integrity understanding and improvements.
• Collaborate with personnel at sites and in leading the implementation of the DI Plan within the assigned sites, including securing support from site leadership.
• Promote DI reporting aligned with Speak Up office for DI relevant cases to assure they are managed appropriately across the interface between the Speak up office and Quality Investigation and corrective/preventative action processes.
• In collaboration with the AveXis Compliance group, provide direct support to sites to assure proper preparedness for regulatory inspections of DI aspects, and proper responses to data integrity related observations.
• Foster and maintain effective relationships with Health Authorities governing the operations within the sites.
• Educate and communicate, including awareness, self-inspections, technical skill building, and behavioral change management.
• Support development of DI tools, training materials and guidance (e.g. Data mapping optimization, Audit trail review) and the roll-out according to defined strategy.
• Keep aligned with Data Integrity developments across industry, with emphasis on Health Authority developments, and report to management as appropriate.

Qualifications

• Minimum B.S. degree; higher level degree: MS, MBA preferred but not required.
• At least 15 years ‘experience supporting manufacturing, quality, and contract supplier/customer interactions; BLA/MAA and PAI experience preferred.
• Experience leading in a diverse global SME matrix environment, with ability to drive and manage change.
• Cross-functional experience in a GxP regulated Pharmaceutical Industry (e.g. Quality Assurance), clinical operations, PV, pre-clinical operations, manufacturing /engineering operations, Quality Management Departments or equivalent external consultant positions with experience in quality risk management through application of ALCOA+ principles and 21 CFR Part 11 requirements.
• Experience in a leadership position in a GxP environment necessary to drive the understanding and implementation of Data Integrity concepts with a large group of stakeholders.
• Strong experience in building DI programs, project management, budget, communication and presentation skills.
• Ability to synthesize detailed information and provide clear communication and messaging across quality, manufacturing and supply chain.
• Expert knowledge and understanding of cGXPs.
• Approximately 30% 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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