Sarah Mac Mullan
over 1 year ago
An expanding biopharmaceutical start-up are about to a launch a product portfolio in the EMEA region and as a result they need to hire an Associated Director QA Operations for the region to be based the EMEA headquarters in Dublin . This organisation specialise in developing biopharmaceutical products to treat rare diseases and ideally are looking for a senior manager quality Assurance to assist with all commercial launches within the EMEA region.
This role will report into a Global Quality Director and will involve the following:
- Manage quality compliance within network of CMO's
- Reviewing and approving product complaints, deviations, change controls and leading product related investigations
- Conducts internal audits and assisting in regulatory agency inspections
- Support the development and implementation of the long-term Quality strategy and provide overall quality oversight to GDP practices
- Conduct QA review of draft GMP and GLP documents, when requested
- Responsible for CAPA and non-conformance management
- Conducts risk-based audits of service providers and internal systems - maintain audit files and tracking log.
- Degree qualification with 5-7 years quality assurance experience within pharmaceutical or biopharmaceutical sector
- Experience of working with contract manufacturing
- Excellent GDP is required and a RP qualification would be a distinct advantage
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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