Global QRM Lead: Risk-Based Quality Management (ICH Q9)

Biogen, Inc.; Cambridge (MA); Hybrid; USD 155,000 - 214,000; Full time

Benefits offered by this job

Competitive benefits package

Bonus and equity incentives

Paid time off and holidays

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen, Inc. is seeking an Associate Director of Global Quality Risk Management to design, implement, and sustain enterprise QRM capabilities aligned with ICH Q9 and global regulatory expectations.

Based in the US with a hybrid role in Cambridge, MA or RTP, NC, you will lead QRM processes across the Quality Management System, drive risk-based decision-making, and mentor teams while partnering with cross-functional stakeholders to ensure inspections readiness and continuous improvement.

Qualifications

• Bachelor's degree in a science, engineering, or related field; MS/PhD preferred.
• 10+ years GMP/Quality experience, including 5+ years leading QRM/QMS.
• Experience implementing ICH Q9-aligned frameworks and coaching teams.
• Experience with health authority inspections and audit preparation.
• Ability to lead global training and mentoring teams.

Responsibilities

• Lead the development and implementation of the enterprise QRM framework aligned to ICH Q9.
• Define and maintain global risk standards, methodologies, tools, and templates.
• Serve as the operational owner and SME for QRM processes.
• Embed risk-based principles into core QMS processes like deviation management and change control.
• Partner with process owners to define risk thresholds and decision criteria.
• Prepare risk summaries for governance forums and senior leadership.

Skills

GMP/Quality

QRM Leadership

ICH Q9

Cross-functional

Training & mentoring

Stakeholder management

Education

Bachelor's degree in Math/Science/Engineering

MS/PhD preferred

Job description

Biogen, Inc. is seeking an Associate Director of Global Quality Risk Management to design, implement, and sustain enterprise QRM capabilities aligned with ICH Q9 and global regulatory expectations.

Based in the US with a hybrid role in Cambridge, MA or RTP, NC, you will lead QRM processes across the Quality Management System, drive risk-based decision-making, and mentor teams while partnering with cross-functional stakeholders to ensure inspections readiness and continuous improvement.