Associate Director - Quality

A start-up Biopharmaceutical company based in Dublin focused on developing and commercializing new products, is currently recruiting for an Associate Director - Quality. This company has a very strong pipeline of development stage products and has grown significantly over the last year. This position will be responsible for QMS management, oversight of GDP practices as well as management of CMO activities.

What you will be doing in the role:

  • Manage CMO Quality activities and conduct weekly project calls.
  • 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.

What you will need:

  • Minimum BSc. in a Scientific related discipline
  • 5+ years' experience in a QA role

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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