02 ago - Milano
Cpl Life Sciences
pstrongJob Title: /strongCMO QA Manager /ppstrongJob Type: /strong Tempo pieno permanent /ppstrongRole Location: /strongMadrid, Spain or Milan, Italy – Hybrid /ppstrongRemuneration: /strong Competitive salary and benefits /ppbr / /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. /ppbr / /ppstrongKey Responsibilities /strong /pulliProvide 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 /ulpbr / /ppstrongCandidate Profile /strong /pulliSignificant 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 /ulpbr / /ppstrongHighly Desirable /strong /pulliExperience 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 /ulpbr / /ppstrongWhat#39;s on Offer? /strong /pulliOpportunity 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 strongMadrid or Milan /strong. /liliInternational travel opportunities as part of a global quality leadership function. /li /ulpbr / /ppPlease note you must be located in the 1 of location share in the location. For more information, please reach out to /p
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