Quality Assurance Leader - Batch Disposition & QMS

Biogen, Inc.; North Carolina; On-site; USD 127,000 - 170,000; Full time

Benefits offered by this job

Medical Insurance

Wellness program

Disability Insurance

Paid time off

Job summary

Biogen is seeking a Sr. Manager, Quality Assurance at the RTP site to provide strategic and operational leadership for batch disposition, compliance oversight, and quality systems supporting clinical and commercial manufacturing.

The role partners with Manufacturing, Engineering, and Quality to ensure product quality and regulatory compliance, while driving continuous improvement and staff development. Applicants should have a strong GMP background, 7+ years in QA, and experience influencing

Qualifications

• Bachelor's degree in a scientific/technical field.
• 7+ years of QA experience in pharma/biotech/manufacturing.
• Experience managing personnel in QA environments.
• Strong knowledge of global regulatory requirements (FDA/EMA) and cGMP.
• Experience with QA systems: batch disposition, investigations, CAPA, change control, document management, validation.

Responsibilities

• Provide final batch disposition decisions for clinical and commercial batches.
• Lead quality oversight across multiple systems at the RTP site.
• Partner with Manufacturing, Engineering, and Quality leaders on risks and initiatives.
• Drive continuous improvement of quality systems and document lifecycle processes.
• Lead internal audits and support regulatory inspections and submissions.
• Hire, develop, and mentor QA team members.

Skills

Quality Assurance

Regulatory knowledge (FDA/EMA)

cGMP standards

Leadership/mentoring

Cross-functional collaboration

Quality systems (CAPA, change control,

Education

Bachelor's degree in scientific/technical field

Advanced degree (MS/MBA)

Tools

Quality systems in manufacturing

Job description

Biogen is seeking a Sr. Manager, Quality Assurance at the RTP site to provide strategic and operational leadership for batch disposition, compliance oversight, and quality systems supporting clinical and commercial manufacturing.

The role partners with Manufacturing, Engineering, and Quality to ensure product quality and regulatory compliance, while driving continuous improvement and staff development. Applicants should have a strong GMP background, 7+ years in QA, and experience influencing