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