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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. Location: This position will be located in Durham, NC and will be able to work on a hybrid schedule. Key responsibilities include: Providing QE expertise to support clinical and commercial gene therapy products. Full audit support of all internal and external audits in support of product manufacturing. Ensuring quality and compliance aspects of design and working in collaboration with Engineering, technical functions, and Manufacturing Operations to ensure that the facility is compliant with all appropriate regulations for GMP manufacturing. Providing strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs and CPPs. Acting as Quality approver on project deliverables, as defined in the project plan. Working with validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Playing a lead role in the planning, execution, and closure of commissioning, qualification, and validation activities from a Quality functional perspective. Authoring and/or approving Standard Operating Procedures in support of project activity and deliverables. Providing QA oversight of engineering, validation, and facilities activities related to maintaining a GMP facility in a validated state. Acting as the Quality approver of change controls, deviations, and CAPAs required to maintain the manufacturing facility in a GMP state. Working 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. Essential requirements include: B.S. degree in preferably engineering, chemistry, or biochemistry. 7 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 CFR's 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. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $103,600 and $192,400 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays, and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an email to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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- English
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