Quality Compliance Specialist

Regeneron seeks a Quality Compliance Specialist to oversee internal change controls and ensure adherence to cGMP and regulatory standards. The role involves reviewing documentation, facilitating cross-functional collaboration, and supporting continuous improvement of quality systems in a fast-growing biopharmaceutical organization.

Responsibilities

• Review, assess, and approve change control documentation for quality and regulatory compliance
• Facilitate cross-functional meetings and provide guidance to change control owners throughout processes
• Develop and implement continuous improvements to change control systems and related procedures
• Support regulatory and customer audits as a subject matter expert
• Analyze process and systems information to support decision-making in cGMP environment

Requirements

• Bachelor's degree in life sciences or related field, or equivalent proven experience
• 2+ years of quality compliance or related experience
• Strong knowledge of cGMP, FDA regulations, ICH guidelines, and global regulatory standards
• Proficiency with MS Word, Excel, and PowerPoint; Veeva/QMS experience preferred
• Demonstrated ability to interpret regulatory requirements and translate into procedures

Compensation: $67,400–$110,000 base