Ensure compliance with US Food, Drug & Cosmetic Act, Section 503A, and all its cGMP elements related to facilities, utilities, warehousing, production, testing, documentation, training, reports and records.
The Global Supplier Quality Manager is responsible for leading a supplier quality engineering team globally to establish and improve the comprehensive supplier quality program, which includes supplier QMS qualification & improvement, supplier strategy, supplier product quality, supplier audit, root cause analysis and 8D effectiveness, supplier quality scorecard and continuous improvements.
In this role, the selected candidate will be responsible for the oversight of all GMP Quality Control activities; review and approve all protocols related to immuno-assay validation, such as ELISA and Flow Cytometry (FACS)
Lead all QC efforts.
Design, develop, and lead implementation and delivery of a global governance model for the quality system professional training program to ensure job-based training requirements are effectively assigned, executed, and managed.
Provides necessary definition, development, and deployment of product/package quality assurance strategy by addressing all phases of product development from water quality and injection molding to the finished package.
Manage a team of Quality Supervisors responsible for QC, exception handling and process audits to achieve release and compliance expectations. Responsible for the overall staff morale and culture of assigned areas.
Plans, develops, and implements appropriate quality systems, controls, and procedures to ensure investigational products conform to product specifications, FDA/MOH regulations and corporate policies and standards.