Senior Expert, Science & Technology - Analytical Equipment Systems

12,000. The number of associates worldwide working together to reimagine medicine! <br><br>The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines..<br><br>The Senior Expert, Science & Technology - Lab Systems, responsible for the lifecycle management of GxP lab systems in the Gene Therapy (GTx) analytical labs in Novartis Technical Research & Development (TRD) from concept, development, validation, implementation and maintenance to retirement.<br><br>• Acts as the SME for GxP lab systems such as LIMS, Empower, and other analytical instruments in the analytical labs in TRD GTx.<br>• Ensures the GxP lab systems are in compliance to all regulatory requirements such as 21 CFR Part 11 and Annex 11.<br>• Day-to-day management and continuous improvement of all GxP lab systems/processes.<br>• Plans and leads large GxP system projects, such as LIMS implementation and lab instrument qualification.<br>• Works with Development Quality, IT, Engineering, and Validation to support GxP lab system lifecycle management activities from concept, development, validation, implementation and maintenance to retirement.<br>• Authors, reviews, reports on and approves corrective actions to protocols, investigations, non-conformance, CAPAs, and other records related to GxP lab systems.<br>• Leads data integrity initiatives related to GxP lab systems.<br>• Reviews, identifies, and leads implementation of improvements to existing lab systems.<br>• Overseas/Creates SOPs and training related to GxP lab systems.<br>• Lead representation of GxP lab systems during meetings.<br>• Oversees and/or communicates and tracks all follow-up items through to completion.<br>• Other related duties as assigned.<br><br>[#video#https://www.youtube.com/watch?v=Mo1vwtVPVA0{#400,300#}#/video#]<br><br>Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.