Description
We are looking for a
GPS Quality Manager 80% (m/f)
Reference: -en
Start: 04/18
Duration: 12 MM
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Provide Global Product Strategy (GPS) staff with compliance support to ensure that GPS regulated activities are conducted in accordance to the the applicable company specific SOPs, guidelines, policies and Health Authority regulations
- Provide Quality Management Support ensuring that regulated GPS activities are executed efficiently, effectively and in compliance
- Implement Quality Management Processes
- Develop and maintain GPS quality standards & metrics for key GPS activities
- Lead and coordinate supplier quality assessment for regulated processes in GPS
- Identify opportunities for improvement
- Execute and oversee processes contributing to Safety Regulatory Documents (PSUR, etc.)
Your qualifications
- University degree preferably in life sciences / biology / medicine or other healthcare discipline
- Profound working experience in Pharmacovigilance in a compliance or Quality Management function
- Strong knowledge of GVP, Healthcare & Medical compliance, SOPs and regulatory requirements
- Demonstrated experience in working in a global organization on improving processes in a regulated environment
- Profound experience in interacting with marketing / Commercial organization in a Pharma environment
- Fluency in English, written and spoken
- Strong analytical and decision making skills in a complex, fast paced and changing environment
- Knowledge of controlled document environments (Touchpoint, Condor, etc.)
- Experience in Quality Risk Management or Quality Management would be an advantage
Skills:
- Quality manager
Keywords: Qualitätsmanager