14 sep
|
Cpl Life Sciences
|
Comunidad de Madrid
14 sep
Cpl Life Sciences
Comunidad de Madrid
Job Title: CMO QA Manager - Audit & Vendor Qualification Job Type: Full-time permanent Role Location: Milan, Italy or Madrid, Spain Remuneration: Up to €60,000 - €65,000 + Bonus Please note this role will be up to 50% of buisiness travel across Europe and internationally. 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 integral 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 manufacturi
📌 CMO QA Manager (Comunidad de Madrid)
🏢 Cpl Life Sciences
📍 Comunidad de Madrid