Cmo Qa Manager

04 ago - Milano
Cpl Life Sciences

ppbRole Location: /bMadrid, Spain or Milan, Italy - Hybrid /ppbRemuneration: /b Competitive salary and benefits /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 experience supporting external manufacturing operations, supplier quality, or CMO oversight activities.
/liliStrong understanding of GMP requirements, quality systems, investigations, CAPAs, and risk management methodologies.
/liliExperience supporting regulatory inspections and audit programmes.
/liliAbility to influence stakeholders and build strong relationships across internal and external partner networks.
/liliExcellent communication, problem-solving, and decision-making skills.
/li /ulh3Highly Desirable /h3ulliExperience within sterile manufacturing, aseptic processing, biologics, or Annex 1 environments.
/liliExpertise in sterility assurance, contamination control strategies (CCS), and data integrity.
/liliExperience supporting technology transfers, product launches, validation, and complex supply chains.
/li /ulh3What's on Offer?
/h3ulliOpportunity to join a growing global pharmaceutical organisation.
/liliHigh-profile role with significant exposure to senior stakeholders and external manufacturing partners.
/liliInternational scope with opportunities to influence quality strategy and culture.
/liliHybrid working arrangement based in either bMadrid or Milan /b.
/liliInternational travel opportunities as part of a global quality leadership function.
/li /ul /p #J-*****-Ljbffr

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