Senior Manager, Data Integrity (Site DI Head)

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.

In this position, the incumbent will drive awareness and own change management activities at the site level to champion and ensure a culture of Data Integrity Excellence. This individual will drive and monitor site progress against the Data Integrity Plan, oversee site implementation of corrective and preventative measures (CAPAs) and related mitigation of risks. In addition, this position must assure appropriate systems and processes to support GxP data integrity.

Responsibilities

• Establish and manage all site DI topics.
• Serve as the site subject matter expert for all DI-related inquiries/trainings and DI assessment tools.
• Identify and maintain a network of functional Data Integrity (DI) Subject Matter Experts (SME)/ DI Champions within appropriate GxP functional areas (e.g. Manufacturing, Maintenance, MS&T, engineering, QA Ops, QC, etc.).
• Determines strategy and collaborates with functional DI SMEs/DI Champions to drive behavioral change management activities to strengthen DI culture.
• Continuously improve data integrity knowledge base and understanding: Identify training needs and ensure availability of appropriate and functionally relevant training materials; where training does not exist, facilitate creation of material and delivery of training.
• Create and participate in design and delivery of activities to engage shop floor associates in strengthening quality culture, leveraging network of functional DI SMEs/DI Champions.
• Drive continuous/sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks, etc.
• Ensure sharing of practices and alignment within stakeholders on key DI topics.
• Manage DI topics at site in investigations, rapid alerts, reviews and audits related to Data Integrity for both internal Novartis and external parties.
• Support preparation for regulatory/health authority inspections and/or response development for DI related topics.
• Facilitate the identification of high-risk data processes and systems (via risk assessment, gap assessment, data mapping, etc.). Identify and champion opportunities for mid and long-term actions and strategies to reduce DI risk.
• Implementation of DI tools, training materials and guidance (e.g. DI Key cards, Data mapping optimization, audit trail review) at the site according to defined strategy.
• Conduct site DI training.
• Drive, monitor and assure delivery of the AveXis DI Plan applicable to your function, including DI communication and engagement plan, and periodically report status/progress to site leadership, AveXis DI lead and Novartis Group Quality as required.
• Keep aligned with Data Integrity developments across industry, with emphasis on Health Authority developments, and report to management as appropriate.
• 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.
• Lead DI escalation for any DI related issues.
• Conduct business reviews at sites to assure progress against DI objectives.
• Perform site level DI risk assessments as defined per procedural requirements.
• Represent the site as part of the AveXis DI network/Steering committee.

Qualifications

• Minimum B.S. degree; higher level degree: MS, MBA preferred but not required.
• At least 8 years' experience supporting manufacturing, quality, and contract supplier/customer interactions; BLA/MAA and PAI experience preferred.
• At least 3 years of direct industry DI related experience.
• Experience working 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 21CFR Part 11 requirements. Strong operational background preferred.
• Strong experience in supporting DI programs, risk analysis, 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 15% 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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