Experteer Overview
In this role you will maintain quality oversight of external CMOs supporting the GE HealthCare PDx division, building strong collaborations to ensure sterile contrast media products meet quality, safety and regulatory expectations. You will act as the single quality contact for contract manufacturers and drive transparency, accountability, and continuous improvement across the supplier network. You will lead audits, CAPA, change controls, and health authority readiness, shaping how external partners contribute to product quality at scale. This position offers meaningful impact through cross‑functional collaboration and ongoing quality improvements.
Retribuzione / Benefits
- Provide quality oversight for multiple Contract Manufacturing Operations
- Serve as the primary quality contact for Contract Manufacturers
- Manage deviations, complaints, regulatory non‑compliances and CAPA
- Develop and maintain Quality Agreements with Contract Manufacturers
- Coordinate and/or lead supplier audits and ensure audit closure
- Oversee Change Controls initiated by supplier or GE Healthcare
- Assist in Health Authority inspection preparations and support
- Track and trend quality indicators to monitor supplier and QMS performance
- Ensure supplier adherence to GE Healthcare QMS and regulatory requirements
- Support New Product Introductions and transfers with quality input
- Drive cost of quality improvements with internal partners (Sites, Sourcing, Supply Chain)
- Perform release‑related activities for Pharmaceutical Products (desirable)
- Other duties as assigned by manager
Responsabilità
- Bachelor's Degree in Science (or equivalent experience)
- Problem solving and root‑cause analysis to drive change
- Proficiency with Excel for data analysis
- Ability to travel up to 30%
