12 set - Italia
Ge Healthcare
We are seeking a Lead QA Specialist – New Product Implementation to provide Quality Assurance leadership for the introduction of new products across a global external manufacturing network.
In this role, you will lead QA oversight of technology transfer to Contract Manufacturing Organizations (CMOs) and support external partners manufacturing products for GE HealthCare-sponsored clinical trials and pharmaceutical partner studies. You will work in a highly collaborative, cross-functional environment, ensuring compliant, right-first-time delivery of new product introductions.
This is an excellent opportunity for an experienced QA professional to work at the interface of development, manufacturing, and external partnerships in a global, matrixed organisation.
Provide QA oversight for new product introduction (NPI) activities, ensuring compliance with GMP and regulatory requirements.
Lead QA support for technology transfer to CMOs, including review and approval of protocols and risk assessments.
Ensure external manufacturing sites are inspection-ready and compliant.
Act as QA lead for external manufacturing partners, ensuring adherence to quality standards and agreements.
Review and approve GMP documentation including batch records, deviations, CAPAs, and validation reports.
Provide QA oversight for manufacture of investigational medicinal products (IMPs) supporting clinical trials.
Support supply of products to pharmaceutical partners for clinical studies.
Act as QA interface during client audits and health authority inspections.
Partner with global cross-functional teams to deliver NPI programs.
Contribute to project governance, risk management, and decision-making.
Drive continuous improvement of NPI and external manufacturing quality processes.
Conduct on-site visits to CMOs to support technology transfer and QA oversight.
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related discipline
Experience in Quality Assurance within a GMP-regulated environment
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