15 ago
|
Cpl Life Sciences
|
Madrid
15 ago
Cpl Life Sciences
Madrid
CMO QA Manager - Integral Pharmaceutical Manufacturing Network
Location: Madrid, Spain/Milan, Italy
Travel: Up to 50% International Travel
I am looking to speak with an experienced CMO QA Manager to provide strategic quality oversight across a global network of contract manufacturing partners.
This is a highly visible role within the Quality function, responsible for ensuring GMP compliance, driving quality excellence, and supporting the successful delivery of products through a complex external manufacturing network. You'll work closely with CMOs, suppliers, internal stakeholders and regulatory authorities, helping to maintain the highest standards of product quality, patient safety and compliance.
Key Responsibilities
Act as the primary Quality contact for assigned CMOs and external manufacturing partners.
Provide QA oversight across commercial manufacturing activities.
Support and conduct GMP audits of CMOs, suppliers and contract service providers.
Oversee Quality Systems activities including Deviations, CAPAs, Change Controls and Investigations.
Lead quality risk assessments and support risk-based decision making in line with ICH guidelines.
Review and approve significant quality events and ensure effective root cause analysis and CAPA implementation.
Support product launches, technology transfers, process validation and continued process verification activities.
Drive inspection readiness activities and support interactions with regulatory agencies.
Monitor quality metrics, identify emerging trends and proactively manage compliance risks.
Support supplier qualification and ongoing supplier performance management.
Lead quality governance meetings and external manufacturing review boards.
Partner with cross-functional teams to drive continuous improvement initiatives across the supply chain.
Provide strategic recommendations relating to quality, compliance and supply continuity risks.
What We're Looking For
7+ years' experience within pharmaceutical Quality and Ma
📌 Quality Assurance Manager (Madrid)
🏢 Cpl Life Sciences
📍 Madrid