03 ago
|
Cpl Life Sciences
|
Bardi
03 ago
Cpl Life Sciences
Bardi
p Job Title: CMO QA Manager p Job Type: Tempo pieno permanent /pp Role Location: Madrid, Spain or Milan, Italy – Hybrid /pp Remuneration: Competitive salary and benefits /pp 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.
/pp 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.
/pp Key Responsibilities /pulli Provide quality oversight for assigned CMOs and external manufacturing partners.
/lili Lead and support GMP audits across contract manufacturers, suppliers, and service providers.
/lili Oversee quality systems activities including deviations, CAPAs, change controls, and investigations.
/lili Conduct quality risk assessments and drive effective risk mitigation strategies in line with ICH Q9 principles.
/lili Review and approve critical investigations, ensuring robust root cause analysis and sustainable CAPA implementation.
/lili Support regulatory inspection readiness and interactions with agencies including FDA, EMA, and MHRA.
/lili Provide quality leadership for technology transfers, process validation, PPQ, and new product introductions.
/lili Lead supplier qualification and ongoing quality performance management activities.
/lili Monitor quality metrics and compliance trends to identify and address emerging risks.
/lili Support quality governance forums and collaborate with cross-functional stakeholders to drive continuous improvement initiatives.
/li /ulp Candidate Profile /pulli Significant experience within pharmaceutical quality assurance and GMP-regulated manufacturing environments.
/lili Proven experience supporting external manufacturing operations, supplier quality, or CMO oversight activities.
/lili Strong understanding of GMP requirements, quality systems, investigations, CAPAs, and risk management methodologies.
/lili Experience supporting regulatory inspections and audit programmes.
/lili Ability to influence stakeholders and build strong relationships across internal and external partner networks.
/lili Excellent communication, problem-solving, and decision-making skills.
/li /ulp Highly Desirable /pulli Experience within sterile manufacturing, aseptic processing, biologics, or Annex 1 environments.
/lili Expertise in sterility assurance, contamination control strategies (CCS), and data integrity.
/lili Experience supporting technology transfers, product launches, validation, and complex supply chains.
/li /ulp What's on Offer?
/pulli Opportunity to join a growing global pharmaceutical organisation.
/lili High-profile role with significant exposure to senior stakeholders and external manufacturing partners.
/lili International scope with opportunities to influence quality strategy and culture.
/lili Hybrid working arrangement based in either Madrid or Milan.
/lili International travel opportunities as part of a global quality leadership function.
/li /ulp Please note you must be located in the 1 of location share in the location.
For more information, please reach out to /p /p
📌 Cmo Qa Manager (Bardi)
🏢 Cpl Life Sciences
📍 Bardi