Senior Manager Product QA
Team Horizon is seeking a Senior Product QA Manager and QP to join our client s team. This is a leadership role and is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs). Relocate? This role is a fully on-site position in Ireland, are you willing to relocate? Do you have authorisation to work in the EU? Why you should apply: This is an excellent opportunity to make an impact on people''s lives across several key therapeutic areas including immunology, oncology and neuroscience. What you will be doing: Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management. Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems. Lead batch review and release, documentation, checks, and test completion. Oversee validation of manufacturing and testing processes and accurate record keeping. Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications. Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA). Chair Change Review Boards, approve changes, oversee completion of ..... full job details .....
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