Global CMO QA Leader – GMP & Audits

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

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