CMO QA Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79v1x1

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.

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 in either Madrid or Milan.
- International travel opportunities as part of a global quality leadership function.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79v1x1