Senior Manager, Global GxP Training

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 Senior Manager, Global GxP Training is responsible for providing global oversight of the training and qualification programs for the GxP business units. The Senior Manager, Global GxP Training will ensure the effectiveness of the program by developing and implementing effective processes and tools for identifying training needs, developing and approving training content, monitoring and reporting compliance to the program, and by developing and managing Quality Systems Training courses.

Responsibilities

• Formulate training procedures, programs, and schedules, based on knowledge of identified training needs, production processes, business systems, or changes in products, procedures, or services.
• Establish and communicate standards for formal training, retraining and competency in association with Quality Systems and applicable regulations.
• Develop, implement and maintain GxP training matrix.
• Work in cooperation and alignment with functional management to design, plan, implement, and access quality-related training programs.
• Facilitate the ‘train-the-trainer' with effective techniques in training.
• Ensure the system is current, standardized, in a state of compliance, and aligned with industry best practices.
• Lead the team to develop and perform the annual GxP refresher training for all sites and remote employees.
• Measure, evaluate and report the effectiveness of the training program.
• Evaluate customer feedback and continuously improve the training program.
• Assist with strategic planning activities to proactively provide effective and efficient learning solutions to business areas.
• Manage and maintain compliance-related training records in a designated, approved systems per procedure.
• Investigate and respond to Quality System issues identified in the Training System (CAPAs, deviations, audit observations, etc.).
• Provide subject matter expertise during audits of the training program and regulatory inspections.
• Assess key performance indicators and respond accordingly.
• Provide innovative ways to develop and sustain the quality culture for the benefit of the business and our patients.
• Mentor and coach team members.

Qualifications

• Bachelor's degree preferred.
• 7+ years of training experience within a regulatory or pharmaceutical environment.
• Demonstrated leadership experience that includes the ability to inspire, foster teamwork, and champion change.
• Experience developing, delivering and assessing instructor led, computer-based, and competency based functional training.
• Solid organizational and time management skills. Proven project management education or experience preferred.
• Ability to multi-task and flex as needed to meet company objectives.
• Strong interpersonal, oral and written communications skills including writing, composition, grammatical skills a must.
• Exceptional facilitation and presentation skills.
• Working knowledge of learning management systems, Microsoft applications including PowerPoint, Excel and Word.
• Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.
• Role will require 25% travel.

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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