Global CMC Quality & Compliance Specialist

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 100.000 - 150.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. seeks a CMC Product Quality Compliance Specialist to support Product Quality Review activities and ensure quality and regulatory compliance across commercial programs. You will collaborate with CMC, QA, Regulatory and CMOs to maintain supply continuity and process efficiency.

The role involves ownership of change management and regulatory submissions, ensuring GMP documentation is in place, and supporting regulatory communications and inspections.

Qualifikationen

• BS/BA in Chemistry, Biology or related field.
• 0–2 years relevant experience for Assoc QA Specialist or equivalent combination of education and experience.
• 2+ years relevant experience for Specialist; 5+ years for Sr Specialist; leadership experience a plus.

Aufgaben

• Oversees the global change management implementation plan.
• Assesses impact of proposed process changes, deviations and CAPAs on end-to-end supply chain.
• Oversees coordination and generation of the annual PQRs and YBPR.
• Reviews quality-related information to detect trends and initiates actions.
• Ensures distribution compliance with global regulatory filings.
• Interacts with global regulatory authorities during Agency inspections.

Kenntnisse

Quality assurance

Regulatory compliance

Change management

Ausbildung

BS/BA in Chemistry, Biology or related field

Tools

BPDR

QDR

Jobbeschreibung

Regeneron Pharmaceuticals, Inc. seeks a CMC Product Quality Compliance Specialist to support Product Quality Review activities and ensure quality and regulatory compliance across commercial programs. You will collaborate with CMC, QA, Regulatory and CMOs to maintain supply continuity and process efficiency.

The role involves ownership of change management and regulatory submissions, ensuring GMP documentation is in place, and supporting regulatory communications and inspections.