Own end-to-end supplier lifecycle under GMP, including qualification, compliant, supplier change, periodic evaluation and decommission, based on a risk-based and phase appropriate procedure, within expected timeline
Job Summary
Own end-to-end supplier lifecycle under GMP, including qualification, compliant, supplier change, periodic evaluation and decommission, based on a risk-based and phase appropriate procedure, within expected timeline.
Develop and execute supplier audit plans, conduct audits of suppliers to identify potential gaps and risks, review observation response and track CAPA implementation.
Proactively participates in company initiatives toward continuous improvement (New Products Introduction, GMP Improvement Programs, etc.) while providing guidance in the area of knowledge and deliver timely results while contributing to quality system improvement.
Matching Summary
Own end-to-end supplier lifecycle under GMP, including qualification, compliant, supplier change, periodic evaluation and decommission, based on a risk-based and phase appropriate procedure, within expected timeline.
Skills & Requirements
Must-have
GMP Supplier Management
Quality Assurance Agreements
Supplier Audits and CAPA
CMO Oversight
GxP regulations and guidance
Nice-to-have
Continuous improvement initiatives
Cross-functional collaboration
Problem-solving and prioritization
Strong ownership and self-motivation
Key Requirements
7+ years QA, QC, manufacturing experience
2+ years material/supplier quality or external manufacturing/testing oversight
Bachelor’s degree or above in pharmaceutical, Chemical, Biology, microbiological or related field