Qa Lead (Hybrid)

Cpl Life Sciences; Bardi; Ibrido; EUR 90.000 - 125.000; Tempo pieno

Descrizione del lavoro

Cpl Life Sciences is partnering with a leading international pharmaceutical organisation to recruit a CMO QA Manager. This role is hybrid, based in Madrid or Milan, and oversees a global network of CMOs and external partners to ensure GMP compliance.

The role requires strong QA leadership, profound knowledge of GMP, audits, CAPAs, investigations, and data integrity, with a track record in sterile manufacturing or Annex 1 environments. Travel to sites may be required.

Competenze

• Significant experience in pharmaceutical quality assurance within GMP environments.
• Experience supporting external manufacturing operations and CMO oversight.
• Strong understanding of GMP, investigations, CAPAs, risk management.

Mansioni

• Lead GMP audits across CMOs, suppliers and service providers.
• Oversee quality systems: deviations, CAPAs, change controls, investigations.
• Review/approve critical investigations with robust root-cause analysis.
• Support regulatory inspection readiness and interactions with FDA, EMA, MHRA.
• Provide leadership on technology transfers, process validation, PPQ, and new product introductions.
• Lead supplier qualification and ongoing quality performance management.
• Monitor quality metrics and trends to address emerging risks.
• Collaborate with cross-functional teams to drive continuous improvement.

Conoscenze

GMP audits

QA leadership

Deviations & CAPAs

Regulatory interactions

Sterile manufacturing

Data integrity

Technology transfers

Descrizione del lavoro

Job Title: CMO QA Manager

Si assicuri di inviare la sua candidatura con tutte le informazioni richieste, come indicato nella panoramica del lavoro riportata di seguito.

Job Type: Full time permanent

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.

• Lead and support GMP audits across contract manufacturers, suppliers, and service providers.
• Oversee quality systems activities including deviations, CAPAs, change controls, and investigations.
• 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.

• 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.
• 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.

Opportunity to join a growing global pharmaceutical organisation.

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. xysqume

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