Associate Director, Enterprise Quality Risk Management
About The Position
As the Associate Director, Enterprise 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 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.
Requirements
- 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.
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 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.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
