Senior Manager, Quality Systems

Role: Senior Manager of Quality Systems responsible for overseeing and improving GxP Quality Management System processes within a virtual biopharma setting. Primary objectives include ensuring compliance with FDA, ICH, EU/EMA regulations, and supporting inspection readiness. Responsibilities encompass managing deviations, investigations, CAPA, change control, quality metrics, and electronic QMS platforms (preferably Veeva). The role involves cross-functional collaboration across Quality, Regulatory, Clinical, and supply functions, providing subject matter expertise, risk-based guidance, and driving continuous improvement. Key tasks include overseeing quality record lifecycle activities, developing SOPs and training materials, analyzing quality metrics, identifying systemic risks, and supporting vendor oversight. The position also entails supporting system implementations, audit preparations, and mentoring staff. Qualifications: 5–10+ years in Quality Assurance or GxP compliance within pharma/biotech, with deep knowledge of regulatory requirements, experience with electronic QMS (Veeva preferred), and proficiency in data analysis tools (e.g., Power BI). Strong communication and stakeholder management skills are essential. The ideal candidate holds a Bachelor’s degree in a scientific discipline, with an advanced degree preferred. This role demands hands-on expertise in quality systems, process optimization, and working in outsourced or lean environments, supporting a pipeline of innovative B-cell therapies. The position reports to Quality leadership and is based in the United States, requiring minimal travel.