Senior Compliance Lead, Pharma Quality & Inspections

Biogen; Milwaukee (WI); On-site; USD 93,000 - 121,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) matching

Employee stock purchase plan

Tuition reimbursement

Paid vacation

Paid holidays

Parental leave

Job summary

Biogen is seeking a Sr. Associate II, Compliance to lead site compliance and inspection readiness at the RTP Drug Substance Manufacturing site. You will partner with site leadership and quality teams to oversee regulatory data integrity and quality systems, driving continuous improvement globally.

You will manage inspection activities, coordinate governance meetings, and provide data-driven metrics using Veeva, TrackWise, and Power BI. A strong regulatory background is essential.

Qualifications

• Bachelor’s degree in scientific, technical, or relevant discipline.
• 5+ years of Quality Assurance in pharma/biotech/manufacturing environments (degree may offset).
• Strong knowledge of cGMP and global regulatory standards (FDA/EMA).
• Experience with inspection management, compliance oversight, and quality systems.

Responsibilities

• Lead site compliance and inspection management activities (planning, execution, regulatory response).
• Ensure site remains inspection-ready for domestic and international regulators.
• Provide oversight of data integrity, risk management, and quality systems.

Skills

Quality Assurance

cGMP knowledge

Inspection management

Data analysis

Regulatory interactions

Communication

Problem solving

Multitasking

Education

Bachelor’s degree in scientific/technical discipline

Tools

Veeva

TrackWise

Power BI

Job description

Biogen is seeking a Sr. Associate II, Compliance to lead site compliance and inspection readiness at the RTP Drug Substance Manufacturing site. You will partner with site leadership and quality teams to oversee regulatory data integrity and quality systems, driving continuous improvement globally.

You will manage inspection activities, coordinate governance meetings, and provide data-driven metrics using Veeva, TrackWise, and Power BI. A strong regulatory background is essential.