QA Compliance Expert / Lead

Job description

Band Level 4 Job Description Summary: Step into a role where quality leadership directly shapes the future of gene therapies. As a QA Compliance Expert / Lead, you will be a trusted voice in ensuring that innovative medicines are developed and commercialized with the highest standards of quality, integrity, and compliance. Partnering closely with manufacturing, development, and global quality teams, you will lead critical quality system activities, mentor others, and drive meaningful improvements that safeguard patients and advance Novartis’ mission to reimagine medicine. 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: - Lead site quality system processes supporting development and commercialization of gene therapy medicines - Serve as subject matter expert for change control, nonconformance, and documentation programs - Drive consistent execution of investigations, root cause analysis, and corrective and preventive actions - Review and approve change controls and nonconformances in alignment with quality...