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

• Blueprint implementation, ?One Site SM BS?, merger of Direct Material Testing Bio DS BS, governance and role definition QA for QC squads (KAU), QA for QC
  • Member of the Quality Leadership Team
  • Group leader for 1-3 QA Managers and 1-3 QA Assistants
  • Responsible for direct material lot disposition for BS/KAU
  • In charge to develop an active QA team for our stakeholder network towards a lean and agile environment
  • Contributor for continuous improvement of the E2E process for direct materials, introduction of release system
  • Accountable QA for QC Support, DMT, PAT, ASAT, CfA
  • Accountable QA for Warehouse BS
  • Support of the Quality Site Head SM DP & QLT
  • Goals, strategies, deliverables, quality oversight, GMP/PQS and regulatory compliance, right to operate, KPIs, inspections at sites
  • Member of local and global teams (supplier qualification, production, MSAT, QC, change control, procurement & logistics)

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)

• Responsible for leading a team of 6 Technical Regulatory Managers and Technical Regulatory Leaders
• Accountable for employee`s deliverables during technical regulatory life cycle activities for assigned biological products
• Support of local and global management for department goals, strategies and deliverables
• Member and leader of local and global teams (regulatory, production, QA/QC, logistics, change control) to provide technical regulatory support
• Training of leadership skills, HR business processes, performance and development management
• Recruiting, onboarding and training of new employees
• Personal coaching and sparring program

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)

• CMC regulatory in global and local teams (production, QA/QC, logistics, change control, site transfer)
• Delivery of regulatory dossiers and responses to Health Authorities for renewals, new registration or changes, DMF

Specific Activities for Technical Regulatory in Mannheim

• Training of local technical regulatory (systems TRIS, SpeCA, ConDoR for CMC, Rapid), liaison with Chugai/Japan, QbD
• Support of site management for team goals, strategic decisions, deliverables and site transfer activities
• Local impact assessment coordinator for global PQS documents

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:

• Development Products with Chemical Drug Substances (CETPi, DPP-IV, GLP-1, HCV, PNP, PPAR, Tarceva, VCAM)
  • CMC regulatory in local and global teams (production, MSAT, QA, QC, supply/logistics, change control)
  • Performance of regulatory CMC strategies from clinical phase I towards launch
  • Delivery of regulatory flexible approaches during drug substance and drug product development
  • Regulatory submissions of quality modules for CTA/INDs for chemical drug products worldwide
  • Delivery & maintenance of IMPD/CMC IND dossiers for clinical phase I-IV trials according to current regulatory requirements in timely manner
  • Efficient handling of Health Authority requests on CMC aspects
• Representing CMC seeking for advice packages to Health Authorities to leverage regulatory strategies
• Realization of Quality-by-Design development for a synthetic peptide project

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)

• Representing CMC regulatory in global supply and technical teams
• Implementation of regulatory strategies
• Regulatory submissions of quality modules for NDA/MAAs for life cycle products world-wide
• Generation and submission of NDA/MAA quality module dossiers for renewals and line extensions
• Responses and of Health Authority requests for CMC topics
• New Product Tarceva 1st Registration NDA/MAA - CTD quality module

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

• Generation of CMC documentation for the initial MAA
• Delivery of regulatory intelligence by continuous evaluation of pharmacopoeias, guidelines and pharmaceutical publications
• Implementation of a database for regulatory and GMP SOPs