Quality Business Partner
Core
Ensuring compliance with GxP regulations for vaccine products, managing batch releases, handling technical complaints, and overseeing quality systems for manufacturing and distribution.
Role type
Quality Business Partner (QA/QC)
Builds
Vaccine BU products and services
Domain
Biopharma / Vaccines
Required skills
GxP regulations knowledge, batch release management, technical complaint handling, cold chain management, quality document management, third-party qualification, risk assessment, regulatory dossier preparation
Preferred skills
Vaccine batch release experience, QA/QC function experience
Technologies
SAP, GxP archiving tools
Responsibilities
Manage national lot release applications and batch release dossiers; Handle product technical complaints and cold chain break events; Support distribution center GSP/GMP implementation; Manage GxP records and third-party quality agreements; Conduct quality risk assessments and audit programs.
Seniority
Mid-level, hands-on IC