CMO QA Manager - Audit & Vendor Qualification

Cpl Life Sciences; Madrid; Híbrido; EUR 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

International travel opportunities

Global exposure to senior stakeholders

Descripción de la vacante

Cpl Life Sciences is seeking a CMO QA Manager to oversee quality activities across a global CMOs network. The role requires GMP compliance leadership, risk management, and strong collaboration with external partners.

It involves substantial travel across Europe and a hybrid work setup with Madrid or Milan as location options. You will drive quality governance, lead audits, support regulatory inspections, and guide technology transfers and process validations to ensure safe, high-quality products

Formación

• Significant experience in pharmaceutical quality assurance and GMP-regulated manufacturing environments.
• Proven ability to oversee external CMOs and supplier quality.
• Strong understanding of GMP, quality systems, investigations, CAPAs and risk management.

Responsabilidades

• Provide quality oversight for assigned CMOs and external manufacturing partners.
• Lead 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 risk mitigation in line with ICH Q9.
• Review and approve critical investigations and ensure robust CAPA.
• Support regulatory inspection readiness and interactions with 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.
• Monitor quality metrics and compliance trends to identify risks.
• Support quality governance forums and cross-functional collaboration for continuous improvement.

Conocimientos

GMP compliance

Quality oversight

Auditing

Stakeholder influence

Communication

Descripción del empleo

Job Type: Full-time permanent

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

• 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.

Please note you must be located in the 1 of location share in the location.