Senior Compliance & Risk Lead — Inspection Readiness

Biogen; Milwaukee (WI); On-site; USD 111,000 - 149,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insurances

401(k) program participation with company matched contributions

Tuition reimbursement up to $10,000

Job summary

Biogen is seeking a Sr. Associate III, Compliance – Risk Management to provide operational leadership at our RTP manufacturing site. This role focuses on quality risk management and ensuring regulatory inspection readiness, driving continuous improvement across quality systems. The ideal candidate has extensive experience in Quality Assurance and a strong understanding of cGMP standards.

In addition to a competitive salary range of $111,000 to $149,000, we offer comprehensive benefits including medical, dental, and tuition reimbursement to foster a motivated and high-performing work environment.

Qualifications

• Minimum 6 years of Quality Assurance experience in pharma or biotech.
• Strong knowledge of cGMP regulations and global standards.
• Experience with quality systems including risk management.

Responsibilities

• Lead site Quality Risk Management (QRM) program.
• Manage inspection readiness and compliance efforts.
• Collaborate to support quality initiatives.

Skills

Quality Assurance experience

Risk management expertise

cGMP knowledge

Analytical skills

Communication skills

Education

Bachelor’s degree in scientific or technical discipline

Job description

Biogen is seeking a Sr. Associate III, Compliance – Risk Management to provide operational leadership at our RTP manufacturing site. This role focuses on quality risk management and ensuring regulatory inspection readiness, driving continuous improvement across quality systems. The ideal candidate has extensive experience in Quality Assurance and a strong understanding of cGMP standards.

In addition to a competitive salary range of $111,000 to $149,000, we offer comprehensive benefits including medical, dental, and tuition reimbursement to foster a motivated and high-performing work environment.