CMO QA Manager - General 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 Manufacturing environments.
- Previous experience supporting external manufacturing operations, CMO oversight, Quality Systems, Validation or Quality Operations.
- Strong understanding of GMP regulations and pharmaceutical quality management systems.
- Experience supporting regulatory inspections and audits.
- Demonstrated experience managing deviations, investigations, CAPAs and quality risk assessments.
- Proven ability to work across multiple stakeholders and influence both internal teams and external partners.
- Experience within complex global supply chains would be highly advantageous.

Desirable Experience
- Sterile manufacturing, aseptic processing or biologics experience.
- Knowledge of EU GMP Annex 1 and contamination control strategies.
- Data Integrity expertise and strong understanding of ALCOA+ principles.
- Technology transfer, process validation and PPQ oversight experience.
- Supplier quality management and contractor oversight.
- Experience leading microbiological, sterility or contamination investigations.
- Exposure to digital quality systems and quality analytics.

Why Apply?
- Opportunity to play a key role within a global pharmaceutical quality organisation.
- Exposure to a diverse international manufacturing network.
- Strategic position with significant visibility across Quality, Operations and Supply Chain functions.
- Involvement in major product launches, technology transfers and continuous improvement programmes.
- Opportunity to influence quality culture and compliance standards across multiple manufacturing sites worldwide.

If this is of interest please get in touch or apply - [email protected]

📌 Quality Assurance Manager (Madrid)
🏢 Cpl Life Sciences
📍 Madrid