GMP-Manager (m/w/d), Springe
Core
Ensuring quality management processes and regulatory compliance for the processing of blood and blood products across multiple manufacturing sites.
Role type
Senior GMP Manager (Quality Management)
Builds
Blood and blood product manufacturing processes compliant with GMP and regulatory standards
Domain
Healthcare / Pharmaceutical / Biotechnology
Required skills
GMP compliance, Quality Management Systems (QMS), Change Control, Deviation Management, CAPA, Document Management, Training & Qualification, Process Validation (CSV), Risk Analysis (GAP/FMEA), GxP Contract Management, Regulatory Trend Analysis, Internal/External Audit Management
Preferred skills
SAP, LIMS, eDMS, Data Integrity knowledge, Technical/Biomedical Engineering background
Technologies
SAP, LIMS, eDMS
Responsibilities
Implement and optimize QM processes, manage change control and deviations, conduct training and equipment qualification, perform risk analyses, harmonize processes across sites, advise departments on quality issues, manage GxP contracts, prepare for and conduct audits
Seniority
Senior, hands-on IC
