Associate CMC Product Quality Compliance Specialist
Core
Overseeing global change management, quality compliance, and regulatory filings for biologic product supply chains.
Role type
Associate CMC Product Quality Compliance Specialist
Builds
Stable drug supply distribution and regulatory compliance for biologic products
Domain
Pharmaceutical / Biologics / Quality Assurance
Deliverable
client delivery
Required skills
Change management, process evaluation, trend analysis, regulatory interaction, procedure development, launch readiness support, deviation reporting, commercial registration request facilitation
Preferred skills
Supervisory experience, leadership experience
Technologies
GMP source documentation, CARRs process, PQRs, YBPRs
Responsibilities
Overseeing global change management implementation plans; Supporting evaluation of process changes, deviations, and CAPAs impact on supply chain; Coordinating annual PQRs and yearly biologic product reports; Assessing quality trends to determine required actions; Ensuring drug supply distribution compliance with global regulatory filings; Interacting with global regulatory authorities during inspections; Developing procedures for change controls and regulatory submissions; Supporting launch readiness and distribution compliance; Providing writing and strategy support for regulatory communications; Facilitating commercial and registration requests process
Seniority
Associate, entry-level specialist with some supervisory experience
