CMO QA Manager - Audit & Vendor Qualification

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

Job Type: Full-time permanent

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