Atsena

The Senior Manager will oversee quality project management for pre-clinical and clinical programs, ensuring GXP compliance across Clinical, CMC, and Nonclinical teams. This includes maintaining the Quality Management System, managing vendor oversight, and leading audit programs and remediation efforts.

Lead global regulatory strategy and execution for gene therapy programs from early research through commercialization. Serve as the primary regulatory liaison for internal teams and global health authorities like the FDA and EMA.

Lead global CMC regulatory strategy and execution for gene therapy programs from early research through commercialization. Act as the primary regulatory liaison between internal CMC teams, external manufacturing organizations, and global health authorities like the FDA and EMA.