CMO QA Manager

Cpl Life Sciences; Milano; Ibrido; EUR 120.000 - 150.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work Madrid/Milan

International travel opportunities

Global exposure

Descrizione del lavoro

Cpl Life Sciences and a leading international pharmaceutical organisation are seeking a CMO QA Manager to oversee quality activities across CMOs and external partners. The role focuses on GMP compliance, quality governance, and ensuring safe, high-quality products for patients worldwide.

You will lead audits, CAPAs, and risk assessments, manage deviations, and support regulatory inspections (FDA, EMA, MHRA).

Competenze

• Significant experience in pharmaceutical quality assurance and GMP environments.
• Strong knowledge of GMP requirements, investigations, CAPAs, and risk management.

Mansioni

• Provide quality oversight for assigned CMOs and external manufacturing partners.
• Lead GMP audits across contract manufacturers and service providers.
• Oversee deviations, CAPAs, change controls and investigations.
• Conduct quality risk assessments and apply ICH Q9 principles.
• Review critical investigations and ensure robust root cause analysis.
• Support regulatory inspection readiness and interactions with FDA, EMA, MHRA.
• Guide technology transfers, process validation, PPQ, and new product introductions.
• Lead supplier qualification and ongoing quality performance management.

Conoscenze

GMP knowledge

QA oversight

Audits & CAPAs

Regulatory liaison

Risk management (ICH Q9)

Stakeholder influence

Formazione

Bachelor's degree in Life Sciences

Strumenti

CAPA software

Quality Management System (QMS)

Descrizione del lavoro

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.