External Manufacturing Compliance Specialist

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY seeks a Compliance Specialist to support External Manufacturing operations and ensure adherence to cGMPs. You will lead change controls and CAPAs, review SOPs, and assist with document control and training.

The role emphasizes collaboration with CMOs/CROs, preparation for inspections, and ongoing process improvements. On-site responsibilities require strong written and verbal communication and proficiency with Veeva and MS Office.

Qualifications

• BS/BA in scientific field required.
• 0-2 years for Associate Specialist, 2+ years for Specialist, 5+ years for Sr Specialist.
• Knowledge of drug product manufacturing from formulation through final packaging.
• Familiar with cGMP, FDA regulations, ICH guidelines and EU regulations.

Responsibilities

• Lead and manage change controls, SCARs, SCNs, NPCs, and CAPAs.
• Review and maintain procedures, policies and other documents with a focus on continuous improvement.
• Maintain knowledge of current good manufacturing practices (cGMPs).
• Support internal and external inspection and audit readiness activities.
• Perform periodic reviews of Drug Product Manufacturing documentation for compliance.

Skills

cGMP compliance

Regulatory compliance

Change controls

CAPA management

Audit readiness

Technical writing

Interpersonal communication

Cross-functional collaboration

Education

BS/BA in scientific field

Tools

Veeva

Opstrakker

Excel

PowerPoint

Visio

Word

Job description

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY seeks a Compliance Specialist to support External Manufacturing operations and ensure adherence to cGMPs. You will lead change controls and CAPAs, review SOPs, and assist with document control and training.

The role emphasizes collaboration with CMOs/CROs, preparation for inspections, and ongoing process improvements. On-site responsibilities require strong written and verbal communication and proficiency with Veeva and MS Office.