QA Specialist
Pubblicato il 23-08-2026 - Ge Healthcare in Varese
Job Description Summary
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.
Job Description
Roles and Responsibilities:
- 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.
- Monitor CMO performance through quality metrics, audits, and governance processes.
- 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.
- Review documentation ensuring it is clear, accurate, and inspection-ready.
- Apply Quality Risk Management (QRM) principles to mitig