Associate Director Quality Assurance Europe
Our client is a global Bio-Pharmaceutical company with offices in the Netherlands, Switzerland, Japan and the US. They are specialized in developing new treatments for patients with rare diseases who have few, if any, treatment options.
The Associate Director QA Europe will oversee the Quality Program in Europe. This includes in the maintenance and obtaining the required licences for distribution of commercial Products, assisting in training and auditing programs as the daily QA activities. Furthermore, the Associate Director will support in New Product Launches and
- Ensure QMS is in line with responsibilities of MA Holder
- Provide Quality Oversight including audits and establishing Quality Technical agreements with CMO's and 3PL's
- Coordinate and oversee product issues in Europe including FMD, complaints and recalls
- Prepare, review and approve external and internal reports required by Regulatory Agencies.
- Provide support and training to other staff members.
- Min. 10 years of experience in pharmaceutical industry
- MSc. in Pharmacy, Chemistry or Life Sciences
- Extensive knowledge of GDP and GMP
- Understanding of FMD is a must
- Experience with Product Launches is an asset
- Working experience as QP/RP is a plus
The position can be based in Utrecht, Switzerland or even homebased.
For more information please contact Seppe Verhoeven at email@example.com or +32 (0) 25 881 277