Quality Compliance Specialist: Change Control & cGMP Expert

Regulatory Jobs; City of Rensselaer (NY); On-site; USD 67,000 - 110,000; Full time

Benefits offered by this job

Student loan paydown program

Tuition reimbursement

Family care benefits

Relocation assistance

Inclusion, culture and well-being

Job summary

Regeneron is seeking a Quality Compliance Specialist to join our Quality Assurance team in Rensselaer, New York. This on-site role focuses on internal change controls and ensuring compliance with cGMP, FDA regulations, and global standards.

You will review and approve change control documentation, facilitate cross-functional meetings, and drive continuous improvements to our change control system. The ideal candidate has 2+ years of experience and a life sciences background, with strong MS Word,

Qualifications

• 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 relationships with end users, serving as a go-to resource on standard change control processes
• Identify, develop, and implement improvements to the change control system, processes, and related procedures
• Interpret compliance and regulatory requirements, translating them into departmental systems and documentation
• Support regulatory and customer audits as a subject matter expert on change control
• Apply strong knowledge of biotech/pharmaceutical quality systems, including cGMP, FDA regs, and ICH standards
• Analyze and interpret process and systems information to support decisions in a cGMP environment
• Leverage MS Word, Excel, PowerPoint; experience with Veeva/QMS is a plus

Responsibilities

• Review and approve change control documentation for compliance
• Lead cross-functional change control meetings and guidance
• Serve as go-to resource for standard change control processes
• Partner to identify and implement continuous improvements to systems
• Translate regulatory requirements into departmental procedures
• Support audits as subject matter expert on change control
• Apply knowledge of cGMP and FDA regulations in daily work
• Analyze process data to support sound decisions in a cGMP environment

Skills

Cross-functional collaboration

Regulatory compliance

MS Word

Excel

PowerPoint

Education

B.S in life sciences

Tools

Veeva

QMS

Job description

Regeneron is seeking a Quality Compliance Specialist to join our Quality Assurance team in Rensselaer, New York. This on-site role focuses on internal change controls and ensuring compliance with cGMP, FDA regulations, and global standards.

You will review and approve change control documentation, facilitate cross-functional meetings, and drive continuous improvements to our change control system. The ideal candidate has 2+ years of experience and a life sciences background, with strong MS Word,