Schlagwörter
Skills
- International Quality Management, CSV, Regulatory Affairsexpert and Auditorwithin the Pharmaceutical and Medical Device industry for major life science companies (Roche, Fresenius, Boehringer Ingelheim, Johnson & Johnson, BASF).
- 9 years of work experiencewithin the life scienceindustry in various positions (Europe & United States).
- CSVand Quality Management specialist with focus onData Integrityand Risk Management.
- GMP Compliance: audit / assessment preparation(for regulatory authorities and clients).
- CSV / GAMP 5trainer in various projects, i.e. during global SAP roll-out.
- Global Project Managementexperience (Europe & United States).
- Expertise in US Health Policy, Reimbursement and Market Access. Specific knowledge of Medicare, Medicaid & FDA regulations. Multiple years of advocacy practice for Medical Device manufacturer in Washington, DC.
Projekthistorie
- Roche Diagnostics Corporation, United States
- Roche Diagnostics,
Germany - Fresenius Kabi, Germany
- Fresenius Kabi Italy
- Fresenius HemoCare Italia
- Fresenius Kabi Polska
- Boehringer-Ingelheim, Germany
- BASF Personal Care and Nutrition GmbH
- Sutter Medizintechnik, Freiburg/DE
- Fresenius Kabi SwissBioSim, Eysin/CH
- Altatec GmbH, Basel/CH, Wimsheim/DE
Reisebereitschaft
Verfügbar in den Ländern
Deutschland, Österreich und Schweiz
Wohnhaft in Barcelona, aber geografisch flexibel