2015 - 2024: Blueprint implementation, ?One Site SM BS?
Rolle: QA Manager for QC / QA Manager Services Ops / QA Manager for Excipients
Kunde: Hoffmann - La Roche Ltd, Basel, Kaiseraugst Switzerland
Aufgaben:
Accountable QA for QC and release of excipients, raw materials, process aids and GMP media for chemical (SM) & bio (LM) DS/DP manufacturing BS/KAU area
2013 - 2015: Marketed DP Biologics
Rolle: Manager Technical Regulatory
Kunde: Hoffmann - La Roche Ltd, Basel, Switzerland
Aufgaben:
Marketed DP Biologics (Avastin, Herceptin, Mabthera, Mircera, Pegasys, NeoRecormon, Roferon-A)
Kenntnisse:
Marketed Biologics
Eingesetzte Produkte:
Avastin, Herceptin, Mabthera, Mircera, Pegasys, NeoRecormon, Roferon-A
2010 - 2013: Support of site management
Rolle: Manager Technical Regulatory
Kunde: Roche Diagnostics GmbH, Mannheim
Aufgaben:
Marketed Products with Chemical & Biological Drug Substances (Fuzeon, Herceptin, Actemra, Avastin)
Specific Activities for Technical Regulatory in Mannheim
Kenntnisse:
Marketed Products (Parenteralia)
Eingesetzte Produkte:
Fuzeon, Herceptin, Actemra, Avastin
2004 - 2010: CMC regulatory in local and global teams
Rolle: Manager Technical Regulatory
Kunde: Hoffmann - La Roche Ltd, Basel, Switzerland
Aufgaben:
Kenntnisse:
Technical Regulatory, Development Products (Small Molecules)
Eingesetzte Produkte:
CETPi, DPP-IV, GLP-1, HCV, PNP, PPAR, Tarceva, VCAM
2000 - 2004: Implementation of regulatory strategies
Rolle: Manager Technical Regulatory
Kunde: Hoffmann - La Roche Ltd, Basel, Switzerland
Aufgaben:
Marketed Products with Chemical Drug Substances (Anexate, Bezalip, Dilatrend, Dormicum, Furtulon, Invirase, Lexotan, Neotigason, Roaccutane, Tarceva, Tigason)
Kenntnisse:
Marketed Products (Small Molecules)
Eingesetzte Produkte:
Anexate, Bezalip, Dilatrend, Dormicum, Furtulon, Invirase, Lexotan, Neotigason, Roaccutane, Tarceva, Tigason
1999 - 2000: Development of a Liquid Formulation
Rolle: Regulatory Affairs and Quality Assurance Manager
Kunde: Grandis Biotech GmbH, Freiburg
Aufgaben:
Development of a Liquid Formulation for Biotechnological-Derived Growth Hormone Somatropine
1994 - 1998
Diploma in Organic, Inorganic, Bio and Physical Chemistry
Albert-Ludwigs-University Freiburg im Breisgau, Germany
Key Focus:
Dissertation: on request
Profile
Based on my 25 years experience I am offering agile and hands on support for technical regulatory or quality assurance projects: CMC submissions & life-cycle, global compliance for chemical and biological drug substances and products. QA support for internal or global multidisciplinary interfaces from external suppliers, goods receipt, warehousing, QA for QC, sampling, release, and documentation management. Due diligence, governance, Deviation, CAPA and Change Management. Experienced in cross-functional collaboration, maintaining GXP compliance and implementing risk-based approaches. Strong reliable partner and communicator with analytical mind-set, passion for your excellence.
Core Competencies
Summary
Soft Skills:
2015 - 2024: Blueprint implementation, ?One Site SM BS?
Rolle: QA Manager for QC / QA Manager Services Ops / QA Manager for Excipients
Kunde: Hoffmann - La Roche Ltd, Basel, Kaiseraugst Switzerland
Aufgaben:
Accountable QA for QC and release of excipients, raw materials, process aids and GMP media for chemical (SM) & bio (LM) DS/DP manufacturing BS/KAU area
2013 - 2015: Marketed DP Biologics
Rolle: Manager Technical Regulatory
Kunde: Hoffmann - La Roche Ltd, Basel, Switzerland
Aufgaben:
Marketed DP Biologics (Avastin, Herceptin, Mabthera, Mircera, Pegasys, NeoRecormon, Roferon-A)
Kenntnisse:
Marketed Biologics
Eingesetzte Produkte:
Avastin, Herceptin, Mabthera, Mircera, Pegasys, NeoRecormon, Roferon-A
2010 - 2013: Support of site management
Rolle: Manager Technical Regulatory
Kunde: Roche Diagnostics GmbH, Mannheim
Aufgaben:
Marketed Products with Chemical & Biological Drug Substances (Fuzeon, Herceptin, Actemra, Avastin)
Specific Activities for Technical Regulatory in Mannheim
Kenntnisse:
Marketed Products (Parenteralia)
Eingesetzte Produkte:
Fuzeon, Herceptin, Actemra, Avastin
2004 - 2010: CMC regulatory in local and global teams
Rolle: Manager Technical Regulatory
Kunde: Hoffmann - La Roche Ltd, Basel, Switzerland
Aufgaben:
Kenntnisse:
Technical Regulatory, Development Products (Small Molecules)
Eingesetzte Produkte:
CETPi, DPP-IV, GLP-1, HCV, PNP, PPAR, Tarceva, VCAM
2000 - 2004: Implementation of regulatory strategies
Rolle: Manager Technical Regulatory
Kunde: Hoffmann - La Roche Ltd, Basel, Switzerland
Aufgaben:
Marketed Products with Chemical Drug Substances (Anexate, Bezalip, Dilatrend, Dormicum, Furtulon, Invirase, Lexotan, Neotigason, Roaccutane, Tarceva, Tigason)
Kenntnisse:
Marketed Products (Small Molecules)
Eingesetzte Produkte:
Anexate, Bezalip, Dilatrend, Dormicum, Furtulon, Invirase, Lexotan, Neotigason, Roaccutane, Tarceva, Tigason
1999 - 2000: Development of a Liquid Formulation
Rolle: Regulatory Affairs and Quality Assurance Manager
Kunde: Grandis Biotech GmbH, Freiburg
Aufgaben:
Development of a Liquid Formulation for Biotechnological-Derived Growth Hormone Somatropine
1994 - 1998
Diploma in Organic, Inorganic, Bio and Physical Chemistry
Albert-Ludwigs-University Freiburg im Breisgau, Germany
Key Focus:
Dissertation: on request
Profile
Based on my 25 years experience I am offering agile and hands on support for technical regulatory or quality assurance projects: CMC submissions & life-cycle, global compliance for chemical and biological drug substances and products. QA support for internal or global multidisciplinary interfaces from external suppliers, goods receipt, warehousing, QA for QC, sampling, release, and documentation management. Due diligence, governance, Deviation, CAPA and Change Management. Experienced in cross-functional collaboration, maintaining GXP compliance and implementing risk-based approaches. Strong reliable partner and communicator with analytical mind-set, passion for your excellence.
Core Competencies
Summary
Soft Skills: