Sr. Associate III, Compliance - QRM Lead

About this role

The Sr. Associate III, Compliance – Quality Risk Management (QRM) Lead provides operational leadership for Biogen’s RTP drug substance manufacturing site, focusing on quality risk management, inspection readiness, data integrity, and compliance systems. The role ensures the site remains in a state of control and inspection‑ready, supporting domestic and international regulatory expectations while driving continuous improvement and fostering a strong compliance culture aligned with cGMP and Biogen Quality Management System standards.

• Lead and manage the site 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 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.

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.

• Bachelor’s degree in a scientific, technical, or relevant discipline.
• 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.

• 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

Base compensation range: $–$. Salary determination is based on a combination of factors including skills, experience, location, and internal equity.

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including fitness reimbursement
• Short‑ and Long‑Term Disability insurance
• Minimum 15 days of paid vacation plus 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 up to $10,000 per calendar year
• Employee Resource Groups participation

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.