Sr. Associate III, Compliance - QRM Lead at External — Research Triangle Park, NC

About this role

The Sr. Associate III, Compliance – Quality Risk Management (QRM) Lead provides operational leadership for Biogen’s RTP drug substance manufacturing site, with a focus on quality risk management (QRM), inspection readiness, data integrity, and compliance systems. This role is responsible for ensuring the site always remains in a state of control and inspection-ready, supporting both domestic and international regulatory expectations. As a key member supporting site leadership, this individual will drive continuous improvement across quality systems while promoting a strong compliance culture aligned with cGMP and Biogen Quality Management System standards.

What you’ll do

• Lead and manage the site Quality Risk Management (QRM) program, ensuring alignment with global policies and site procedures
• Maintain and oversee QRM repositories and lifecycle management within the Quality Management System
• Serve as the site Subject Matter Expert (SME) for risk management during audits and regulatory inspections
• Drive inspection management activities including scheduling, execution, response coordination, and regulatory requests
• Lead implementation and continuous improvement of risk management practices across the site
• Collaborate cross-functionally to support compliance, data integrity, and quality initiatives
• Facilitate governance meetings and influence stakeholders to adopt best practices in risk management
• Support development of QRM training and enable risk facilitators across the organization
• Use data and established KPIs to monitor compliance and drive continuous improvement

Who you are

You are a quality and compliance leader with strong expertise in risk management and a passion for driving continuous improvement in regulated manufacturing environments. You thrive in cross-functional settings, influence stakeholders effectively, and bring a proactive, inspection-ready mindset to all aspects of your work.

Required skills

• Bachelor’s degree in scientific, technical, or relevant discipline
• At minimum 6 years of Quality Assurance experience in pharmaceutical, biotech, or manufacturing environments
• Strong knowledge of cGMP regulations and global regulatory standards (e.g., FDA 21 CFR 210/211, ICH Q9)
• Experience with quality systems including risk management, change control, deviation management, and inspection readiness
• Ability to analyze complex data, make decisions under pressure, and lead critical initiatives
• Excellent communication, organizational, and stakeholder management skills

Preferred skills

• Master’s degree (MBA, MS, or similar) with relevant experience
• Experience leading site-wide or global quality risk management programs
• Strong background supporting regulatory inspections and audit responses
• Demonstrated ability to influence cross-functional teams and drive cultural change in quality and compliance
• Advanced knowledge of quality metrics and data-driven decision making

The base compensation range for this role is: $111,000.00-$149,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

• 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

Why Biogen?