02 ott - Italia
Cpl Life Sciences
Job Type: Full-time permanent Role Location: Milan, Italy or Madrid, Spain Please note this role will involve up to 50% business travel across Europe and internationally. Cpl 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. Working 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.
Key Responsibilities
Provide quality oversight for assigned CMOs and external manufacturing partners. Lead and support GMP audits across contract manufacturers, suppliers, and service providers. Oversee quality systems activities including deviations, CAPAs, change controls, and investigations.
Conduct quality risk assessments and drive effective risk mitigation strategies in line with ICH Q9 principles. Review and approve critical investigations, ensuring robust root cause analysis and sustainable CAPA implementation.
Support regulatory inspection readiness and interactions with agencies including FDA, EMA, and MHRA. Provide quality leadership for technology transfers, process validation, PPQ, and new product introductions. Lead supplier qualification and ongoing quality performance management activities. Monitor quality metrics and compliance trends to identify and address emerging risks. Support quality governance forums and collaborate with cross-functional stakeholders to drive continuous improvement initiatives.
Candidate Profile Significant experience within pharmaceutical quality assurance and GMP-regulated manufacturing environments. Proven experience supporting external manufacturing operations, supplier quality, or CMO oversight activiti
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