.The Senior 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.About the RoleMajor accountabilities:Provides QE expertise to support clinical and commercial gene therapy products. Full audit support of all internal and external audits in support of product manufacturing.Ensures Quality and Compliance aspects of design and works in collaboration with Engineering, technical functions, and 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 of meeting intended design goals of output volume, turnaround time, and operating and product costs.Provides strategic quality 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, ensuring successful validation of the facility. Plays a lead role in the planning, execution, and closure of commissioning, qualification, and validation activities from a Quality functional perspective.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 of change controls, deviations, and CAPAs required to maintain the manufacturing facility in a GMP state.Other related duties as assigned.Must be able to travel to the Durham, N.C. site for board of health audits as needed.Minimum Requirements:B.S. degree in preferably engineering, chemistry, or biochemistry.5 years of experience in biopharmaceutical-based GMP manufacturing operations.Experience with viral gene therapies, cell culture technologies, and/or orphan disease indications is a plus.Strong knowledge and application of the CFRs and cGMPs.Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.Direct experience with commissioning, qualification, and validation to meet FDA and other health authority requirements.Experience with deviations, CAPAs, and Change Controls.Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product-related investigations and deviations.Excellent oral and written communication skills with strong technical writing experience required
