Compliance Specialist, External Manufacturing
Core
Lead and manage change controls, SCARs, SCN's, NPCs, and CAPAs for the manufacturing of life-changing medicines.
Role type
Compliance Specialist (External Manufacturing)
Builds
Regeneron drug products
Domain
Biopharmaceutical manufacturing / cGMP compliance
Required skills
cGMP knowledge, regulatory compliance (FDA, ICH, EU), change control management, CAPA management, audit readiness, technical writing, Veeva, Opstrakker, Excel, Visio
Preferred skills
CMO/CRO collaboration experience
Responsibilities
Lead and manage change controls, SCARs, SCN's, NPCs, and CAPAs; Review and maintain procedures, policies, and instructional documents; Support internal and external inspection and audit readiness; Conduct periodic reviews of Drug Product Manufacturing documentation and records; Maintain required training status on work instructions and SOPs; Implement continuous process improvement.
Seniority
Specialist (2+ years experience) to Sr Specialist (5+ years experience)