Senior Quality Compliance Associate

Role: Quality Assurance specialist ensuring GxP compliance in clinical and manufacturing processes for CNS-focused biopharma products. Responsibilities: conduct and oversee GCP, GLP, and internal audits; review deviations, investigations, OOS, CAPAs, change controls, and validation documentation; maintain and update compliance systems aligned with FDA regulations; support regulatory inspections and product release; update SOPs and stay current with CFR/FDA guidance. Requirements: B.S. in life sciences; 4+ years GMP/GCP experience; strong knowledge of GMP, GCP, GLP standards; proficiency in MS Office; excellent communication and technical writing skills; ability to work independently and collaboratively, with high integrity. HighValue: CNS therapeutic area, clinical and manufacturing compliance, GxP audits, FDA regulatory interface, validation, and product release support. WorkSetup: hybrid, US-based; travel ~25%.