15 ott - Milano
Cpl Life Sciences
ppbJob Type: /b Full-time permanent /ppbRole Location: /bMilan, Italy or Madrid, Spain /ppPlease note this role will involve up to 50% business travel across Europe and internationally. /ppCpl Life Sciences is partnering with a leading international pharmaceutical organisation to recruit a CMO QA Manager. This is an exciting opportunity for an experienced quality professional to take ownership of quality oversight activities across a global network of Contract Manufacturing Organisations (CMOs) and external partners. /ppWorking within a highly visible international quality function, you will play a key role in ensuring GMP compliance, driving quality excellence, and supporting the delivery of safe, high-quality products to patients worldwide. /ph3Key Responsibilities /h3ulliProvide quality oversight for assigned CMOs and external manufacturing partners. /liliLead and support GMP audits across contract manufacturers, suppliers, and service providers. /liliOversee quality systems activities including deviations, CAPAs, change controls, and investigations.
/liliConduct quality risk assessments and drive effective risk mitigation strategies in line with ICH Q9 principles. /liliReview and approve critical investigations, ensuring robust root cause analysis and sustainable CAPA implementation. /liliSupport regulatory inspection readiness and interactions with agencies including FDA, EMA, and MHRA. /liliProvide quality leadership for technology transfers, process validation, PPQ, and new product introductions. /liliLead supplier qualification and ongoing quality performance management activities. /liliMonitor quality metrics and compliance trends to identify and address emerging risks. /liliSupport quality governance forums and collaborate with cross-functional stakeholders to drive continuous improvement initiatives. /li /ulh3Candidate Profile /h3ulliSignificant experience within pharmaceutical quality assurance and GMP-regulated manufacturing environments. /liliProven ex
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