Sr. Manager, Quality Assurance

Role: Senior Manager, Quality Assurance responsible for strategic and operational leadership of batch disposition, compliance, and quality systems supporting clinical and commercial manufacturing at Biogen's RTP site. Responsibilities include overseeing quality oversight activities, final batch disposition decisions, partnering with manufacturing and engineering teams to address compliance and operational challenges, and leading quality system improvements such as investigations, CAPA, change control, and audits. The role involves analyzing quality metrics, supporting regulatory inspections, and managing a team of quality professionals. Requirements: Bachelor's in a scientific or technical field, at least 7 years of QA experience in pharma, biotech, or manufacturing, with prior personnel management, and strong knowledge of global GMP and regulatory standards (FDA, EMA). Preferred qualifications include an advanced degree, experience in clinical and commercial manufacturing, success in quality system enhancements, and audit/regulatory inspection support. High-Value: biologics/biotech manufacturing, GMP compliance, batch disposition, quality systems, and cross-functional collaboration. Work setup: onsite at RTP; no specific travel details provided.