QA Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79y2ku

Experteer Overview In this role you lead QA for the introduction of new products across a global manufacturing network, ensuring compliant and right-first-time delivery. You will oversee technology transfer to CMOs and support external partners manufacturing products for clinical studies, partnering with cross-functional teams to enable successful NPI programs. You drive quality governance, risk management, and inspection readiness across external sites. This position offers impact at the interface of development, manufacturing, and external partnerships within a matrixed, global environment.
Retribuzione / Benefits QA oversight for new product introduction activities ensuring GMP/regulatory compliance
Lead QA support for technology transfer to CMOs including review of protocols and risk assessments
Ensure external manufacturing sites are inspection-ready and compliant
Act as QA lead for external manufacturing partners
Review and approve GMP documentation (batch records, deviations, CAPAs, validation reports)
Monitor CMO performance via quality metrics, audits, governance




QA oversight for manufacture of IMPs for clinical trials and support for pharmaceutical partners
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 for clarity, accuracy, and inspection readiness
Apply Quality Risk Management to mitigate risks
Support deviation management and CAPA implementation
Drive continuous improvement of NPI and external manufacturing quality processes
Conduct on-site visits to CMOs to support transfer and QA oversight
Responsabilità Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related discipline
Experience in Quality Assurance within a GMP-regulated environment
Experience in NPI, technology transfer, validation, or external manufacturing
Experience working with CMOs
Knowledge of glo

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79y2ku