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
ZEITLICHE UND RÄUMLICHE VERFÜGBARKEIT
Wohnhaft in Barcelona, aber geografisch flexibel
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