About this roleThe 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 doLead and manage the site Quality Risk Management (QRM) program, ensuring alignment with global policies and site proceduresMaintain and oversee QRM repositories and lifecycle management within the Quality Management SystemServe as the site Subject Matter Expert (SME) for risk management during audits and regulatory inspectionsDrive inspection management activities including scheduling, execution, response coordination, and regulatory requestsLead implementation and continuous improvement of risk management practices across the siteCollaborate cross-functionally to support compliance, data integrity, and quality initiativesFacilitate governance meetings and influence stakeholders to adopt best practices in risk managementSupport development of QRM training and enable risk facilitators across the organizationUse data and established KPIs to monitor compliance and drive continuous improvementWho you areYou 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 skillsBachelor’s degree in scientific, technical, or relevant disciplineAt minimum 6 years of Quality Assurance experience in pharmaceutical, biotech, or manufacturing environmentsStrong 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 readinessAbility to analyze complex data, make decisions under pressure, and lead critical initiativesExcellent communication, organizational, and stakeholder management skillsPreferred skillsMaster’s degree (MBA, MS, or similar) with relevant experienceExperience leading site-wide or global quality risk management programsStrong background supporting regulatory inspections and audit responsesDemonstrated ability to influence cross-functional teams and drive cultural change in quality and complianceAdvanced knowledge of quality metrics and data-driven decision making Job Level: ManagementAdditional InformationThe base compensation range for this role is: $111,000.00-$149,000.00Base 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.Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:Medical, Dental, Vision, & Life insurancesFitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insuranceA 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 yearPaid Maternity and Parental Leave benefit 401(k) program participation with company matched contributionsEmployee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participationWhy Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.