Global Quality Risk Leader — ICH Q9 & QMS (Hybrid)

Biogen; Milwaukee (WI); Hybrid; USD 155,000 - 214,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insurances

401(k) program with company match

Paid Maternity and Parental Leave

Job summary

Biogen seeks an Associate Director of Global Quality Risk Management to develop and implement enterprise QRM frameworks that meet global standards. This pivotal role involves connecting risk principles with decision-making processes to enhance operational quality.

Applicants should have at least 10 years of GMP and Quality experience with proven leadership abilities. The position offers a hybrid work model and competitive compensation.

Qualifications

• 10+ years of GMP and Quality experience, including 5+ years leading QRM.
• Experience implementing ICH Q9-aligned frameworks.
• Demonstrated ability in health authority inspections.

Responsibilities

• Lead the development and implementation of the enterprise QRM framework.
• Define global risk standards and methodologies.
• Prepare materials for health authority inspections.

Skills

GMP and Quality experience

Leadership in QRM

Risk assessment techniques

Strong partnership skills

Education

Bachelor's Degree in Math, Science, Engineering, or related field

Advanced degree (MS/PhD)

Job description

Biogen seeks an Associate Director of Global Quality Risk Management to develop and implement enterprise QRM frameworks that meet global standards. This pivotal role involves connecting risk principles with decision-making processes to enhance operational quality.

Applicants should have at least 10 years of GMP and Quality experience with proven leadership abilities. The position offers a hybrid work model and competitive compensation.