13 ago - Roma
Cpl Life Sciences
Job Title: CMO QA ManagerJob Type: Full time permanentRole Location: Madrid, Spain or Milan, Italy – HybridRemuneration: Competitive salary and benefitsCpl Life Sciences is partnering with a leading international pharmaceutical organisation to recruit a CMO QA Manager.
Di seguito troverà tutto ciò che deve sapere su questa occasione e sui requisiti richiesti ai candidati.
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 ResponsibilitiesProvide 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 ProfileSignificant experience within pharmaceutical quality assurance and GMP-regulated manufacturing environments.Proven experience supporting ext
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