CMO QA Manager

Cpl Life Sciences; Madrid; Híbrido; EUR 110.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work

International travel

Global exposure

Descripción de la vacante

Cpl Life Sciences is partnering with a leading international pharmaceutical organisation to recruit a CMO QA Manager. This role has global accountability for quality oversight across CMOs and external partners, ensuring GMP compliance and quality excellence to patients worldwide.

You will lead audits, investigations, CAPAs, and risk management, interfacing with regulators and senior stakeholders. The position offers a hybrid setup based in Madrid or Milan with international travel.

Formación

• Significant experience in pharmaceutical QA and GMP environments.
• Proven experience with external manufacturing and CMO oversight.
• Strong GMP knowledge, investigations, CAPAs, and risk management.
• Experience supporting regulatory inspections and audit programmes.
• Ability to influence stakeholders and build relationships across networks.

Responsabilidades

• 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.

Conocimientos

GMP compliance

QA oversight

Audits

CAPA management

Regulatory inspections

Risk management

Technology transfer

Quality systems

Cross-functional leadership

Descripción del empleo

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.