In the Netherlands they are a relatively small office with much growth potential. This Biotech company is dedicated to improving the lives of patients fighting rare diseases. There mission is to make a real difference to patients by developing new medicines.
Responsible for Quality and Regulatory Compliance for GDP (and GMP) in Europe.
- Oversee QA program in Europe; this includes establishing and maintaining the required licenses for distribution activities in Europe;
- Provide Quality oversight including performing audits and establishing Quality agreements
- Quality operations compliancy
- Increase the overall effectiveness of the Quality department together with other departments
- Auditing intern and extern
- Establish and maintain a risk-based and scientific-based quality system
- Assist in other quality assurance related activities as agreed with management.
- GDP’s and cGMPs.
- At least 8 years of QA experience in regulated industry such as pharmaceutical, biologics or device.
- Minimum MS degree in Pharmacy, Chemistry, Life Science or related discipline.
- Must have excellent communication skills (verbal and written).
- Fluent in English. Knowledge of other European languages are a plus.
- This position should be located in the Netherlands and relocation considered. Approximately 30% travel.