Quality Compliance Specialist (Change Controls)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Join our Quality Assurance team as a Quality Compliance Specialist focusing on internal change controls.

About the role

This position ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to change control activities. It offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory, and SOP requirements
• Facilitate cross-functional meetings, offering guidance and consultation to change control owners throughout the process
• Build strong relationships with end users, serving as a go-to resource on standard change control processes
• Partner with quality assurance colleagues and system end users to identify, develop, and implement continuous improvements to the change control system, processes, and related procedures
• Interpret compliance and regulatory requirements, translating them into departmental systems, procedures, and documentation
• Support regulatory and customer audits as a subject matter expert on change control
• Apply strong working knowledge of biotech/pharmaceutical quality systems, including cGMP, FDA regulations, and familiarity with ICH guidelines and global regulatory standards
• Analyze and interpret process and systems information, technical procedures, reports, and regulations to support sound decision-making in a cGMP environment
• Leverage strong digital proficiency in MS Word, Excel, and PowerPoint; experience with Veeva/QMS is a plus

Requirements

• B.S. in life sciences or related field; may substitute proven experience for education requirement
• Associate Quality Compliance Specialist: 0-2+ years of experience
• Quality Compliance Specialist: 2+ years of experience
• Level will be determined based on experience

Schedule

Monday-Friday, 8am-4:30pm

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)
• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits, 401(k) company match
• Health and wellness programs, fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Pay

Salary Range (annually): $62,355.00 - $110,000.00