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, 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

Job Level: Management

Additional Information

The base compensation range for this role is: -

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.

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 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?

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.

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