Senior QA Leader - GMP & Compliance Excellence

Biogen; Milwaukee (WI); On-site; USD 127,000 - 170,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Paid Vacation

Holidays

401(k) Plan

Employee Stock Purchase

Tuition Reimbursement

Parental Leave

Fitness Reimbursement

Employee Resource Groups

Job summary

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

This high-visibility role partners across Manufacturing, Engineering, and Quality to ensure product quality and regulatory compliance, lead a team of professionals, and drive continuous improvement, audits, and regulatory inspections.

Qualifications

• Bachelor's degree in scientific, technical, or relevant discipline from an accredited college or university.
• 7+ years of Quality Assurance experience in pharma/biotech/manufacturing environments.
• Experience managing personnel in a QA environment.
• Strong knowledge of global regulatory requirements (FDA/EMA) and cGMP standards.
• Experience with QA systems including batch disposition, investigations, CAPA, change control, document management, and validation activities.

Responsibilities

• Lead QA oversight activities across multiple quality systems to ensure product safety, quality, and efficacy.
• Provide final batch disposition decisions for clinical and commercial batches.
• Partner with Manufacturing, Engineering, and Quality leaders to address compliance risks and strategic initiatives.
• Drive continuous improvement of quality systems (change control, CAPA, investigations, documentation).
• Analyze site quality metrics, identify trends, and implement solutions.
• Lead internal audits and support regulatory inspections and submissions.
• Hire, develop, and lead a team of quality professionals; manage department priorities and resources.
• Serve as a key quality representative on cross-functional/global teams.

Skills

Quality Assurance

Regulatory compliance

cGMP knowledge

Team leadership

Cross-functional collaboration

Quality batch disposition

Education

Bachelor's degree in science/engineering

Advanced degree (MS or related)

Job description

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

This high-visibility role partners across Manufacturing, Engineering, and Quality to ensure product quality and regulatory compliance, lead a team of professionals, and drive continuous improvement, audits, and regulatory inspections.