Global CMO QA Manager - GMP, Audits & Tech Transfers

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

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.