The Quality Assurance Engineer is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at Novartis Gene Therapies, Durham, N.C. Location: This position will be located in Durham, NC and will be able to work on Hybrid schedule Key Responsibilities: Provides QE support for clinical and commercial gene therapy products. Support of all internal and external audits in support of product manufacturing. Ensures Quality and Compliance aspects of design and work in collaboration with Engineering, technical functions, Manufacturing Operations to ensure that the facility is: Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing. Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications. Capable to meet intended design goals of output volume, turnaround time and operating and product costs. Provides input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters). Acts as Quality approver on project deliverables, as defined in the project plan. Works with validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Authors and/or approves Standard Operating Procedures in support of project activity and deliverables. Provides QA oversight of engineering, validation, and facilities activities related to maintaining a GMP facility in a validated state. Acts as the Quality approver for change controls, deviations, and CAPAs required to maintain the manufacturing facility in a GMP state. Works with supplier and Vendor Management colleagues to ensure that suppliers of goods and services for the new manufacturing facility are compliant and capable of fulfilling their contracted requirements.