Associate Director - Quality

A start-up Biopharmaceutical company based in Dublin focused on developing and commercializing new orphan drug products, is currently recruiting for an Associate Director – Quality. This organisation has recently set up a new European operation in Ireland having recently launched in Europe with an impressive portfolio of products in various stages for the treatment of rare diseases. This role will be focused on the management of Quality Operations, Commercial activities and GDP practices for the EMEA region. If you are looking for a new challenge and to get in at ground level within a start-up environment, then this will be the perfect role for you.

 What you will be doing in the role:

  • Support QA Operations for the EMEA region
  • Responsible for all WDA activities and perform the role of RP where required
  • Work with CMO’s to develop a strategy, define and track metrics as well as management of daily/weekly correspondence
  • Responsible for the review and approval of Master Batch Records
  • Manage and maintain the Quality Management System
  • Conduct product quality reviews and provide monthly metrics
  • Support all GDP activities
  • Responsible for managing customer complaints, deviations, CAPAs and change controls in relation to commercial products
  • Provide QA support to serialization activities – write SOPs, review/approve validation protocols, tract change controls, etc.
  • Support vendor/supplier qualification and management

What you will need:

  • Minimum BSc. in a Scientific related discipline
  • 7+ years' experience in a QA role
  • Experience dealing with third party vendors and CMO’s is essential

The Next Step for you...

Should this position be of interest to you please forward your CV to Emma Wickham from Next Generation Recruitment or alternatively call on the main line on +353 1 6629120.

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