Senior QC Engineer, CMC / GMP QA
Core
Senior subject matter expert providing long-term hands-on support for CMC and GMP documentation review, QC documentation analysis, and inspection readiness for pharmaceutical development.
Role type
Senior IC CMC/GMP Quality Consultant
Builds
Regulatory-ready CMC and QC documentation packages for drug substance and drug product development
Domain
Pharmaceutical/Biotechnology (CMC, GMP, Quality Control)
Required skills
CMC documentation review, GMP compliance assessment, regulatory gap analysis, QC documentation review, investigation support, corrective action planning, vendor documentation review, technology transfer support
Preferred skills
Early-to-late-stage development program support, CDMO and external lab collaboration, technology transfer readiness, regulatory inspection support, electronic document management systems
Technologies
QMS platforms, electronic document management systems
Responsibilities
Review CMC documentation (specifications, batch records, validation, stability), assess GMP compliance (FDA/EMA/ICH), identify gaps and recommend corrections, support QC documentation and investigations, assist with inspection readiness, collaborate with CMC/QA/Regulatory teams
Seniority
Senior, hands-on IC
