Compliance SpecialistⅠ/合规专员Ⅰ
Core
Ensure site compliance with Chinese drug regulations and GMP standards, manage manufacturing licenses, and coordinate quality system processes at the Wuxi site.
Role type
Compliance Specialist (Pharmaceutical Manufacturing)
Builds
Regulatory compliance framework and quality management processes for drug manufacturing
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
China GMP knowledge, Drug Manufacturing License management, Regulatory monitoring and gap analysis, Internal audit coordination, Supplier quality management, Annual Product Report (APR) preparation, Data integrity management
Preferred skills
Quality management experience, Government inspection support, Cross-functional coordination, Lean manufacturing principles, Six Sigma methodologies, AI tool usage
Technologies
GMP systems, AI tools (ChatGPT, Microsoft Copilot)
Responsibilities
Manage site Drug Manufacturing License application and renewal; Monitor and interpret Chinese drug regulations; Act as Local Process Owner for Quality System processes; Support GMP inspections and internal audits; Manage material supplier compliance; Assist in new product registration and post-approval changes; Coordinate Annual Product Reports (APRs); Implement quality management reviews; Promote data integrity culture
Seniority
Mid-level, hands-on IC
