Sr. Manager, Quality Assurance

Biogen seeks a Senior Manager of Quality Assurance to lead quality oversight, batch disposition, and compliance activities at the Research Triangle Park manufacturing site. This leadership role partners across manufacturing and engineering functions to ensure product safety and regulatory compliance while managing a team of quality professionals.

Responsibilities

• Lead quality oversight across multiple systems to ensure safety, efficacy, and product quality at the RTP facility
• Provide final batch disposition decisions and assessments for clinical and commercial manufacturing batches
• Drive continuous improvement of quality systems including change control, CAPA, investigations, and document lifecycle
• Manage quality metrics analysis, identify trends, and implement solutions to improve compliance performance
• Hire, develop, and lead a team of quality professionals while managing department resources and priorities

Requirements

• Bachelor's degree in scientific, technical, or relevant discipline
• Minimum 7 years of Quality Assurance experience in pharmaceutical, biotech, or manufacturing
• Prior experience managing personnel in a quality assurance environment
• Strong knowledge of FDA, EMA, and cGMP regulatory requirements
• Experience with batch disposition, investigations, CAPA, change control, and validation
• Ability to lead cross-functional initiatives and drive continuous improvement

Compensation: $127,000-$170,000 base