Global CMO QA Lead - GMP Compliance & Audits

Cpl Life Sciences; Milano; Ibrido; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Cpl Life Sciences is partnering with a leading international pharmaceutical organisation to recruit a CMO QA Manager. This is an exciting opportunity to take ownership of quality oversight across a global network of CMOs and external partners, ensuring GMP compliance and driving quality excellence.

Based in Milan, Italy or Madrid, Spain, the role involves up to 50% travel across Europe, with international exposure and collaboration with a high-profile quality leadership function to support

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Quality assurance

GMP compliance

CMO oversight

Audits

Regulatory readiness

Quality systems

Descrizione del lavoro

Cpl Life Sciences is partnering with a leading international pharmaceutical organisation to recruit a CMO QA Manager. This is an exciting opportunity to take ownership of quality oversight across a global network of CMOs and external partners, ensuring GMP compliance and driving quality excellence.

Based in Milan, Italy or Madrid, Spain, the role involves up to 50% travel across Europe, with international exposure and collaboration with a high-profile quality leadership function to support