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.
Responsible for Global Engineering and Facilities (GEF) business process/program management activities supporting the manufacturing, process development and clinical supply for the AveXis facilities. This includes managing the CMMS, Calibration, and HEPA Certification programs cross-functionally as well as through critical external development partnerships.
Management of timelines and deliverables of program development, and other projects executed at development partners and CMOs if necessary.
Managing processes, aligning with the Quality Management System (QMS), and driving maturity of those processes/programs.
Communicating program statuses, issues, assessing risks, and proposing solutions to the team(s) and management.
Provide management team with weekly/monthly metrics and progress dashboards reflecting status of all managed processes and associated program maturity activities.
Highlight and escalate issues along with mitigation options/solutions.
Oversee the CMMS, Calibration, and HEPA Certification programs, including Internal Audits, program Non-conformance reporting, assigned Corrective and Preventive Actions, Feedback/Complaints and others, as directed by supervisor.
Interact with IT department to ensure CMMS requirements are provided.
Manage and participate in development and implementation of quality system policies, procedures and work instruction.
Support internal and external audits.
Review audit reports and take responsibility for appropriate response to program level non-conformities and opportunities for improvement.
Participate on GEF process teams and/or working groups, as required.
Maintain compliance with all company policies, quality systems, and procedures.
Bachelor's Degree in Engineering, Engineering Technology (minimum of 8 years' experience) or Minimum of 10 years' experience effectively implementing/managing CMMS business processes and aligning to a QMS.
Experience in participating in audits and/or inspections by certifying and Regulatory Agencies
Experience developing, implementing, and managing the processes/programs as well as presenting to certifying and regulatory bodies. Attention to detail with an ability to create and review program documentation
Ability to collaborate effectively with multiple disciplines
Ability to communicate clearly and effectively, both verbally and written.
Ability to work independently
Ability to multitask and work within a fast-paced dynamic team environment
Creative problem solver
Collaborative working style.
Knowledge and understanding of cGMPs.
15-20 % 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.