11/2022 - ...: Pharma industry, Head of Quality Assurance ad-interim

05/2022- 12/2022: Speransa Therapeutics: interim Head of Quality

05/2020- 12/2022: Boehringer Ingelheim: cGMP consultant for QA/QM topics for Drug Device Combination Products

11/2021-01/2022: ISO 9001 for lawyers: Streitbörger, Germany

08/2021- 05/2022: Fresenius Kabi, Norway:, cGMP consultant - implementation assessments of global QA SOPs

09/2020- 07/2022: Austar Group, China: conception and execution of remote training sessions, e.g. EU GMP Annex 16; MAH concept, Third Party Management

09/2020 - 04/2021: BioNTech SE: cGMP consultant for Supplier Lifecycle Management and QAA?s

01/2020 - 12/2020: Münzprägstatt München: QM and Management consultant

03/2020-06/2020: Pharma industry (Dr Müller, Switzerland) cGMP consultant: gap assessment / risk analysis of production process & QMS

11/2019-01/2020: Life sicence industry, consultant for medical device development (Hauni Vaping Technologies GmbH, Germany)

06/2019 - 11/2019

Pharma industry, Medac GmbH, interims manager and consultant for MDR implementation

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05/2019 - 03/2020

Medical Device Industry, DePuy Synthes (a Johnson&Johnson company), Switzerland: QM consultant for CAPA, investigation / inspection preparation (TÜV, MDSAP)/ risk management

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06/2018 -12/2020

Chemical industry, cGMP consultant (Kuraray Europe), gap assessment / risk analysis of production process for GMP compliance

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05/2018 -04/2019

Pharma industry, cGMP consultant (Merck Darmstadt), regulatory CMC compliance, module 3 CTD, in-licensing of generics

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01/2018 -05/2018

Medical Device Instudry: QM consultant (Siegrist AG, Switzerland), preparation and accompanying for ISO 13485:2016 certification.

• Task Force Member: [Name and URL on request]
• Member of ISPE/A3P aseptics commenting group for Annex 1

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05/2017 - 08/2017

Medical Device Industry: Quality management consulting, auditing (Winka AG, Switzerland)

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03/2017 -04/2018

Medical Device Industry, Germany (Fresenius Medical Care):
FDA readiness. Remediation. CAPA and Deviation Management.

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04/2016 - 06/2017

Medical Device Instudry: QM consultant (Siegrist AG, Switzerland), preparation and accompanying initial ISO 13485 certification. QMS Gap assessment, Risk management (ISO 14971)

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07/2014 - 03/2017

Pharma:

cGMP consultant (Merck Darmstadt), FDA readiness project, gap assessment and risk analysis (ICH Q9) of batch record review and QP batch certification process. Project Management, Deviation Management, Change Control.

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09/2013 - 06/2014

Medical Device Industry: Interim-Manager, Head of Quality, (Depuy Synthes - a Johnson & Johnson company, Switzerland) 9 direct reports, 60 persons within Quality Organisation:
Member of the Management team. Responsible to oversee: NCR-, CAPA- and Complaint- Management, Management Review, Quality Issues, Quality KPI Reporting, Training, Quality
Inspection, Quality Planning, Validation, Calibration

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06/2013-08/2013

Medical Device Industry: CAPA SME (Depuy Synthes - a Johnson & Johnson company, Switzerland): Warning letter remediation as part of a global compliance project. Interim-CAPA review board leader.

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02/2013 ? 05/2013

Novartis PharmOps, Stein, Aargau, Switzerland
Head of QA Compliance Steriles (sterile center of excellence within Novartis worldwide) with 10
direct reports

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04/2012 ? 12/2012

Sanofi Deutschland, Frankfurt am Main, Germany

Group Leader Complaint Management at Site Frankfurt Insulin with two teams / 16 direct reports

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04/2010 ? 03/2012

Boehringer Ingelheim Corporate Center, Ingelheim, Germany
Senior Manager Corporate Quality Assurance, Corporate Division Quality
Global Process Owner Complaints

• Leading BI?s matrix organization for complaint officers worldwide
• Global database owner.
• Develop and perform worldwide trainings on complaints, recalls and OOS

Global Process Owner Recalls (Deputy)

• Lead international, multidisciplinary crisis teams to decide actions of (potential) recall situations
  due to signals from pharmaceutical complaints, escalated medical risks/complaints, OOS during
  stability, other quality defects or inquiries from authorities like FDA, TGA, KFDA, Anvisa
• Communicate and follow-up of decided actions at global level.

Project Team Member of:

• Cross-functional, multisite, operational excellence team ?allowable cost of compliance?
• ?BI?s global IT Landscape of the future? for global QA and QC processes

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03/2005 ? 03/2010

Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
Head of Complaint Management Germany within Process Quality Assurance / Quality Operations,
leading 3 groups / 15 employees
Responsible person for medical devices in Germany and the EU (Sicherheitsbeauftragter für
Medizinprodukte) as laid down in §30 Medizinproduktegesetz
Defend the Complaint Management group in audit situations. Participated in about 40 inspections from
different authorities (FDA, Anvisa, German authorities, KFDA, customers)
Qualified co-auditor at BI Pharma GmbH & Co KG

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10/2000 ? 02/2005

Boehringer Ingelheim Vetmedica GmbH, Ingelheim, Germany
Senior Manager Analytical Development, Animal Health
Laboratory leader of 2 laboratories: ?Analytical Development? and ?New analytical Technologies?.

• Coordination of external developments in US and Europe during pre-formulation, formulation
  finding and NADA/scale-up batches.
• Member of the evaluation / auditing team for several raw material suppliers and contract
  manufacturers / packagers and excipients in Europe and US, e.g.: Glatt, USA, Patheon Canada,
  Patheon UK, Univet Ireland, Tropon (Meda) Germany, Lonza Switzerland

CMC Project team leader of international development projects:

• Product 1 Chewable Tablets: (registered in EU/US): CMC coordination between Glatt NJ/USA,
  PCI PA/USA, Analytical Sciences Biberach and Tropon Germany
• Product 2 (registered in Europe): CMC coordination with Univet/Ireland
• Flavor: development of new artificial flavor with BI Vetmedica US, Symrise /Germany and
  Pharmalyticon / Germany
• Product 3 Suspension: CMC coordination between Glatt NJ/USA, PCI PA/USA, Analytical
  Sciences BI and BI Vetmedica US
• Product 4 injectable: external development project at Patheon /UK

Method development and Validation in accordance to VICH-guidelines, sampling & release of clinical trial material, performance of stability studies; specification finding and cGMP-Documentation: HPLC,
dissolution, HPLC-MS/MS, capillary electrophoresis

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10/1998 ? 09/2000

Ferring Pharmaceuticals, Kiel, Germany
Analytical Development
Responsible for analytical development of one NCE project in preclinical trials an, human clinical trials

Phase I / II:

• Internal & external development of analytical methods for synthesized and isolated
  peptides/proteins: identity, assay, degradation with HPLC, CE, SEC, GC and GC-MS, NMR, CD,
  FT-IR, analytical ultracentrifugation, elemental analysis.
• Qualification of contract labs within Europe. M-Scan (Geneva, Switzerland), Huntingdon Life
  Science, Huntingdon, UK), TNO (Utrecht, The Netherlands), Huntingdon Life Sciences (Eye, UK),
  BioRelliance (Heidelberg, Germany), CAT Gerhardt GmbH, Tübingen, Germany), University of
  Geneva (Pharma Department), Pharmapeptides (Geneva, Switzerland).
• internal/external validation of analytical Methods in accordance to ICH-guidelines, performance of
  stability studies; specification finding and cGMP-documentation
• coworker for registration dossiers (CMC-part of CTX and IND)
• Coordination of bioanalytical method development and validation for preclinical studies (toxicology, preclinical safety, pharmacokinetic and metabolism studies)
• member of Project team "liquid phase synthesis (cooperation with external partner)"