Associate Director, Global Quality Risk Management

About This Role:

As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence. Leading the charge in designing, implementing, and sustaining the enterprise Quality Risk Management (QRM) capabilities, your role is pivotal in aligning with ICH Q9 and global regulatory expectations. Reporting to the Director of Quality Risk Auditing & Governance, you will be the primary enterprise lead for the execution of QRM, ensuring that risk-based thinking is interwoven into our Quality Management System (QMS), operational decision-making processes, and organizational culture. Your leadership will drive the standardization of QRM methodologies, fostering organizational capability and enhancing practical applications of risk assessment, communication, and governance across all GxP activities. This role is essential in embedding risk principles into core processes, bringing immense value to the business by enabling science- and data-driven decisions.

This is a hybrid role that can be based either at our offices in Research Triangle Park, NC or Cambridge, MA.

What You’ll Do:

• Lead the development and implementation of the enterprise QRM framework aligned to ICH Q9.
• Define and maintain global risk standards, methodologies, tools, and templates for consistent application.
• Serve as the operational owner and subject matter authority for QRM processes.
• Embed risk-based principles into core QMS processes like deviation management and change control.
• Partner with QMS process owners to define risk-based thresholds and decision criteria.
• Define consistent risk language and communication practices for effective cross-functional understanding.
• Prepare clear risk summaries for governance forums and senior Quality leadership.
• Support risk escalation processes within the governance framework.
• Lead enterprise ICH Q9 training and coaching programs tailored to specific roles.
• Build capability in risk assessment techniques and documentation quality.
• Cultivate a culture of risk-based thinking through mentoring and communities of practice.
• Partner with the Director, Quality Risk Auditing & Governance to support governance forums.
• Prepare materials for health authority inspections and external audits pertaining to risk-based decisions.
• Monitor evolving external expectations related to QRM and recommend proactive alignment actions.

Who You Are:

You are a strategic thinker with a strong ability to embed risk-based principles into organizational processes. Your experience and enthusiasm for quality risk management make you a natural leader, capable of fostering collaboration across diverse teams. You possess a keen eye for detail and thrive in environments where you can mentor others and drive cultural change. Your passion for advancing organizational capability and your proactive approach to aligning with external expectations set you apart as an innovator in quality risk management.

Required Skills:

• Bachelor’s Degree (BS) in Math, Science, Engineering, or related field; advanced degree (MS/PhD) preferred.
• At least 10 years of GMP and Quality experience, including 5+ years leading QRM and/or QMS process integration.
• Demonstrated experience in implementing ICH Q9-aligned frameworks and coaching teams on risk assessment techniques.
• Experience in health authority inspections and audit preparation.
• Capability in deploying global training and mentoring teams.
• Strong partnership skills across global, cross-functional organizations.