Job Type: Full-time permanent

Envíe su solicitud a continuación después de leer todos los detalles y la información de apoyo sobre esta ocasión de trabajo.

Role 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 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

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- 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

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- 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

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- 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?

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- 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. xhfqzwm

- International travel opportunities as part of a global quality leadership function. xkdbapo

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