QA Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d82qz

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.

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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 to work at the interface of development, manufacturing, and external partnerships in a global, matrixed organisation.

Roles and Responsibilities

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- 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 inspect

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d82qz