EU Quality Director

Walker Cole International is searching for a European Quality Director to join a Pharmaceutical client based in Dublin who are looking to grow out and establish their presence in Europe. This role can predominantly be based remotely.

You will be responsible for:

• Leading and managing the GMDP Quality team based in Dublin ensuring companies to GMP and GDP regulations
• Driving and establishing the Quality strategy for Europe, working closely with the UK team to define MIA/WDA strategy
• Developing and maintaining strong relationships with various regulatory agencies e.g. HPRA, EMA
• Overseeing quality systems, including CAPAs, deviations, change controls etc.  

The successful candidate will have/demonstrate:

• Significant experience working in Quality Assurance in the Pharmaceutical industry adhering to GMP and GDP regulations
• Extensive experience working closely with the HPRA and other EU regulatory bodies
• Prior experience as a Qualified Person or Responsible Person would be advantageous
• An ability to act independently and utilise your own initiative to deal with tasks/issues

Quality Assurance | QA | GDP | Good Distribution Practice | RP | Responsible Person | Pharmaceutical | Audit | Self- Inspection |WDA | MHRA | Change Control | CAPA | Deviations | Root Cause Analysis | Quality | HPRA | Quality Manager | Head of Quality | GMP | Good Manufacturing Practice | EMA | QP | Qualified Person