30 ago
|
Cpl Life Sciences
|
Bardi
30 ago
Cpl Life Sciences
Bardi
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: Tempo pieno 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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📌 Qa Lead (Hybrid) (Bardi)
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