Descripción de la oferta
CMO QA Manager - Global Pharmaceutical Manufacturing Network
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.
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.
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.
Provide strategic recommendations relating to quality, compliance and supply continuity risks.
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.
~ Demonstrated experience managing deviations, investigations, CAPAs and quality risk assessments.
~ Experience within complex global supply chains would be highly advantageous.
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.
Supplier quality management and contractor oversight.
Exposure to digital quality systems and quality analytics.
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.
Opportunity to influence quality culture and compliance standards across multiple manufacturing sites worldwide.
