Job Title: CMO QA Manager Job Type: Tempo pieno permanent Role Location: Madrid, Spain or Milan, Italy – Hybrid Remuneration: Competitive salary and benefits 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 activities. * Strong understanding of GMP requirements, quality systems, investigations, CAPAs, and risk management methodologies. * Experience supporting regulatory inspections and audit programmes. * Ability to influence stakeholders and build strong relationships across internal and external partner networks. * Excellent communication, problem-solving, and decision-making skills. Highly Desirable * Experience within sterile manufacturing, aseptic processing, biologics, or Annex 1 environments. * Expertise in sterility assurance, contamination control strategies (CCS), and data integrity. * Experience supporting technology transfers, product launches, validation, and complex supply chains. Whats on Offer? * Opportunity to join a growing global pharmaceutical organisation. * High-profile role with significant exposure to senior stakeholders and external manufacturing partners. * International scope with opportunities to influence quality strategy and culture. * Hybrid working arrangement based in either Madrid or Milan. * International travel opportunities as part of a global quality leadership function. Please note you must be located in the 1 of location share in the location. For more information, please reach out to [email protected]

📌 CMO QA Manager (Milano)
🏢 Cpl Life Sciences
📍 Milano