Quality Assurance Engineer

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The Quality Assurance Engineer is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at Novartis Gene Therapies in Durham, NC.

Durham, NC – Hybrid schedule.

• Provide QE support for clinical and commercial gene therapy products.
• Support all internal and external audits in product manufacturing.
• Ensure quality and compliance in facility design and work with Engineering, Manufacturing Operations and Technical functions to maintain GMP compliance, safety, effectiveness and cost goals.
• Translate commercial product requirements into technical solutions meeting defined CQAs and CPPs.
• Act as Quality approver on project deliverables per the project plan.
• Define initial asset life‑cycle model, qualification and validation strategy for facility validation.
• Author and/or approve Standard Operating Procedures for project activities.
• Oversee engineering, validation and facilities activities to keep the GMP facility validated.
• Approver for change controls, deviations and CAPAs to maintain GMP status.
• Collaborate with supplier and Vendor Management to ensure compliant goods and services for the new manufacturing facility.

• B.S. degree in engineering, chemistry or biochemistry.
• 5 years’ experience in Biotech/Pharmaceutical industry or 4 years’ experience with at least 2 years within Novartis Gene Therapies.
• Experience with viral gene therapies, cell culture technologies and/or orphan disease indications is a plus.
• Strong knowledge and application of 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.
• Ability to synthesize data and summarize outcomes to recommend compliant paths forward.

The salary for this position is expected to range between $85,400 and $158,600 annually. The final salary offered is determined based on relevant skills and experience and will be reviewed periodically. Compensation includes performance‑based cash incentive, eligibility for annual equity awards and a comprehensive US‑ benefits package (health, life, disability, 401(k) with match). Time‑off benefits include vacation, personal days, holidays and other leaves.

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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.

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of this position, please contact us at tale or call . Please include the job requisition number in your message.