7 days ago
An expanding specialist pharmaceutical organization who has grown significantly through acquisition in recent years is looking to hire a new Head of Quality for the Dublin based EMEA headquarters. This organization currently has products in excess of thirty global products outside of the US and is looking to expand this product portfolio into new markets through M&A and also organic growth. As a result, they need a new Quality Director to head up the EMEA function to ensure the company is compliant with all regulatory and quality processes across multiple markets.
- This role will report into an SVP Technical Operations and will head up the Quality function for all markets outside of the US.
- This role will prepare and host the EU site regulatory inspections from a WDA, Manufacturing Importation Authorization (MIA), Marketing Authorization Holder (MAH) or Pharmacovigilance (PV) perspective.
- This position will for leading resolution of open investigations, deviations, Corrective Action Preventative Actions (CAPA) and change controls together with the Qualified Person (QP) and Responsible Person (RP) to ensure timely release of supplies to market.
- This position will be responsible for all quality operations and investigations across all contract manufacturers and distributors in all markets outside of US.
- This position will be focused on ensuring all quality and compliance protocol are met in relation to new product introductions and market launches.
- Provide support and oversight of batch review and disposition (and perform such disposition when required), reviewing and approving product complaints, deviations, change controls, and leading product related investigations.
- Maintain quality and regulatory compliance to ensure that there are no significant regulatory agency citations associated with any company specific GMP/GDP activities.
- Ensure all quality agreements are met by existing and new third party suppliers across manufacturing and distribution as the organisation continues to expand.
- Implement and maintain a best-in-class quality management system.
Degree quailed with a science related area and 10-12-year quality operations experience with pharmaceutical or biopharma organisation.
Extensive quality assurance and product launch is required.
Ideally RP qualified.
The Next Step for you:
Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1662 9120
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