CMO QA Manager - Global 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 general 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 wit
📌 Quality Assurance Manager (Comunidad de Madrid)
🏢 Cpl Life Sciences
📍 Comunidad de Madrid
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