GMP Quality Manager
Core
Ensuring Manufacturing and CMO activities comply with GMP, local regulations, and Quality Agreements while overseeing the Quality Management System.
Role type
Quality Manager (GMP/CMO oversight)
Builds
Reliable and predictable pharmaceutical supply chain
Domain
Pharmaceuticals / Regulatory Compliance
Required skills
GMP compliance, Quality Management Systems (QMS), supplier qualification and audits, CAPA management, regulatory change control, batch record review, complaint investigations, annual product quality reviews, electronic document management systems
Preferred skills
Sterile manufacturing knowledge, eQMS experience, virtual wholesaling understanding
Technologies
Electronic document management systems
Responsibilities
Oversee QMS for GMP/GCP operations, conduct supplier qualification and quality audits of CMOs, review batch records and support product release, manage regulatory change control processes, lead QA function for product launches, execute Quality System tools (Change Controls, Deviations, CAPAs), maintain domestic and international regulations
Seniority
Mid-Senior, hands-on IC
