CMO QA Manager - Audit & Vendor Qualification
Pubblicato il 05-10-2026 - Cpl Life Sciences in Milano
Job Type: Full-time permanent
Scorra verso il basso per trovare i dettagli completi dell'offerta, inclusa l'esperienza richiesta e le mansioni associate.
Role Location: Milan, Italy or Madrid, Spain
**Please note this role will involve up to 50% business 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
- 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. xysqume
- International travel opportunities as part of a global quality leadership function.
#J-18808-Ljbffr