CMO QA Manager - Audit & Vendor Qualification

ppbJob Type: /b Full-time permanent /ppbRole Location: /bMilan, Italy or Madrid, Spain /pp**Please 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 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 /h3ullibExperience within sterile manufacturing, aseptic processing, biologics, or Annex 1 environments. /b /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. /liliInternational travel opportunities as part of a global quality leadership function. /li /ul /p #J-18808-Ljbffr