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 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
Job Level: Management
