03 oct
|
Cpl Life Sciences
|
España
03 oct
Cpl Life Sciences
España
Job Title: CMO QA Manager - Audit & Vendor Qualification
Job Type: Full-time permanent
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 general 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.
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.
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.
Ability to influence stakeholders
📌 CMO QA Manager (España)
🏢 Cpl Life Sciences
📍 España