Principal Consultant and QA / QM Auditor for pharmaceutical- and Med-Tech-Industry

1/2015 – 12/2020

Head of QA Technics and Service Provider Management within TR&D Basel
• Leading a team of 10 QA Subject Matter Experts in the field of small Molecules and
Biologics for Qualification & Validation activities related to Drug Substance, Drug
Product and Combination Products (ISO13485)
• Leadership for quality oversight of process/cleaning validation, Automation and
Computer validation, Quality Risk Management, Change-Control, CAPA, Discrepancy
Management and Equipment qualification activities in production and analytical areas
• Global Lead for Service Provider and Supplier Qualification in TR&D (300 Companies)
• Execution of more than 70 audits as Lead Auditor in the last 5 years

Technisches Qualitätsmanagement / QS / QA

1/2010 – 1/2015

• QA Managing of Combination Products (MDR) including Product Release
• QA Lead and responsibility for two new construction projects in Basel and Kaiseraugst
150 mCHF new facility for Medical Device)
• Managing and providing of QA Subject Matter Expertise for:
• Qualification of Production Equipment (sterile formulations)
including Process Automation according to GAMP5 and CSV activities
• End to End Aseptic Process Validation (Sterilization, Mediafill, CIP/SIP, VHP)
• Facilities zone concept, Critical Utilities (PW, WFI, Steam) incl. Risk-Mgmt.
• Preparation of the departments for Swissmedic GMP-Inspections
° ISO13485 Qualitymanagement from Development to Commerzial

Technisches Qualitätsmanagement / QS / QA

1/2008 – 1/2014

QA Manager (Main responsible QA) for
TR&D Neubau für alle galenischen Formen (Capex 400 Mio.)

Projektbeschreibung QA Verantwortung (End-to-End) für ein neues Produktionsgebäude für die technische Forschung und Entwicklung in Basel. Leitung eines Teams von 5-8 QA Managern.
Betreuung des Projektes in CD, BD, DD >> IQ,OQ,PQ >> Lieferantenmanagement >> Inspektionsvorberitung und Moderation der Behördenabnahme durch Swissmedic.
Resultate des Projektes: In-Time, In-Budget, GMP-Compliant (ohne Beanstandungen bei der behördlichen Abnahmeinspektion), Gewinner des Facility of the Year Awards in der Kategorie Projektmanagement

Technisches Qualitätsmanagement / QS / QA

1/2002 – 5/2006

Group Lead GMP Compliance Manager in QC Biotech
• Lead the GMP team to implement an improved quality system for QC Biotech.
Approval of all department SOPs as Author or QC Manager.
• Primary responsibility for Qualification, Calibration and Maintenance of Analytical
Equipment, Archiving GMP documentation, Preparations for authority’s inspections

Qualitätssicherungssysteme

1/1995 – 5/2000

Quality Assurance Manager for QC “EU Release”
• Responsible for compliance and further development of the GMP Quality System
• Review and approval of all SOPs, Deviation-/Investigation-Reports, EquipmentQualification-Plans/Reports, Method-Validation, Method-Transfers
• Execution of Self-Inspections and preparations for authority’s inspections
• Member of the QC Leadership-Team

Laboratory Head EU Release Analytics
• Laboratory Head of 7 laboratories within the EU Release Department
• Leading a team of 12 laboratory technicians in the field of Small Molecules and
Biologics QC testing activities related to: Drug Substance and Drug Product
• Plan and manage resources to provide analytical support to Roche Basel HQ
• Managing and providing of QC Subject Matter Expertise for:
• Analytical Method-Development, -Validation and -Transfer (in and out)
• Fully automated analytical systems for HPLC and dissolution testing

Laboratory Head centralized Chromatography
• Laboratory Head of 3 HPLC laboratories
• Leading a team of 5 laboratory technicians in the field of HPLC testing activities for:
Vitamins, small molecules drug products, various Roche Grenzach OTC products
• Executing HPLC Method-Development and Validation.
• Supervisory review and approval of QC results and reports

Technisches Qualitätsmanagement / QS / QA