ph3Experteer Overview /h3pIn 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. /ph3Retribuzione / Benefits /h3ulliQA oversight for new product introduction activities ensuring GMP/regulatory compliance /liliLead QA support for technology transfer to CMOs including review of protocols and risk assessments /liliEnsure external manufacturing sites are inspection-ready and compliant /liliAct as QA lead for external manufacturing partners /liliReview and approve GMP documentation (batch records, deviations, CAPAs, validation reports) /liliMonitor CMO performance via quality metrics, audits,



governance /liliQA oversight for manufacture of IMPs for clinical trials and support for pharmaceutical partners /liliAct as QA interface during client audits and health authority inspections /liliPartner with global cross-functional teams to deliver NPI programs /liliContribute to project governance, risk management and decision-making /liliReview documentation for clarity, accuracy, and inspection readiness /liliApply Quality Risk Management to mitigate risks /liliSupport deviation management and CAPA implementation /liliDrive continuous improvement of NPI and external manufacturing quality processes /liliConduct on-site visits to CMOs to support transfer and QA oversight /li /ulh3Responsabilità /h3ulliBachelor's degree in Life Sciences, Pharmacy, Chemistry, or related discipline /liliExperience in Quality Assurance within a GMP-regulated environment /liliExperience in NPI, technology transfer, validation, or external manufacturing /liliExperience working with CMOs /liliKnowledge of global regulatory requirements (FDA, EMA, ICH) /li /ul /p #J-18808-Ljbffr

📌 QA Specialist - NPI (Cusano Milanino)
🏢 Experteer Italy
📍 Cusano Milanino