Job Type: Full-time permanentRole Location: Milan, Italy or Madrid, Spain**Please note this role will be up to 50% of buisiness travel across Europe and internationally.**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 integral 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.What's 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.- 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.#J-18808-Ljbffr

📌 Cmo Qa Manager - Audit & Vendor Qualification (Madrid)
🏢 Cpl Life Sciences
📍 Madrid