QA Compliance Specialist

Job description

Band Level 3 Job Description Summary: In this role, you’ll be at the heart of ensuring quality, compliance, and trust as we advance innovative gene therapies for patients worldwide. As a QA Compliance Specialist, your expertise will directly shape how quality systems are applied, strengthened, and continuously improved across the site—supporting both development and commercialization. You’ll partner closely with cross-functional teams, influence critical decisions, and serve as a trusted voice on compliance, helping turn complex challenges into clear, risk-based solutions that protect patients and products alike. Location: - This position will be located in Durham, NC and will be a Hybrid role. - Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Key Responsibilities: - Establish and maintain site quality system processes supporting development and commercialization of advanced gene therapy medicines - Drive consistent execution of change control and non-conformance programs aligned with global quality system standards - Lead investigations, root cause analysis, and timely corrective and preventive actions using a...