Biotech QA Change Control Specialist, cGMP

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 67,000 - 110,000; Full time

Benefits offered by this job

Annual bonuses or incentive plans

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, 9

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY seeks a Quality Assurance Compliance Specialist, Change Control to ensure cGMP compliance and effective change control processes.

You will review change control documents, lead cross‑functional discussions and advise on best practices while supporting audits and continuous improvement initiatives. The role emphasizes independent work, strong attention to detail, and collaboration with QA and end users to uphold global regulatory standards.

Qualifications

• Bachelor's in scientific or engineering field with relevant experience in quality/regulatory
• Experience with cGMP, FDA regulations and global regulatory expectations
• Proven ability to work independently with attention to detail and scientific judgment
• Strong communication skills and ability to influence across levels
• Proficient in MS Word, Excel and PowerPoint; digital literacy required

Responsibilities

• Review, assess, edit, and approve change control documentation per quality, regulatory and SOP requirements
• Facilitate cross-functional meetings and guide change proposal owners
• Advise end users on best practices in Change Control
• Partner with QA team and system users to improve the Change Control system
• Identify, develop, and implement continuous improvements to the Change Control process
• Interpret regulatory requirements for inclusion in procedures and documentation
• Support regulatory and customer audits

Skills

cGMP knowledge

FDA regulations

ICH guidelines

Attention to detail

Cross-functional

MS Office

Change control

Education

Bachelor's in science/engineering

Tools

QUMAS

Job description

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY seeks a Quality Assurance Compliance Specialist, Change Control to ensure cGMP compliance and effective change control processes.

You will review change control documents, lead cross‑functional discussions and advise on best practices while supporting audits and continuous improvement initiatives. The role emphasizes independent work, strong attention to detail, and collaboration with QA and end users to uphold global regulatory standards.