Thomas (W.) Höhle

Sales Partner

Mainz, Germany
Experience
Feb 2025 - Present
6 months

Sales Partner

SourceWeb Group

Consulting and sales of cybersecurity

Aug 2024 - Dec 2024
5 months

Senior CSV Consultant

Valicare GmbH

Support for various projects in software validations, QMS and ISMS audits (ISO 9001 and ISO 27001), responding to customer questionnaires, and GAMP® workshops; B2B customer acquisition; setting up the CSV training department.

Oct 2023 - Jan 2024
4 months
Sumiswald, Switzerland

Validation Expert & Lead Auditor

PB Swiss Tools AG

Validation expert & lead auditor for medical devices; audit of an IT infrastructure cloud service provider for cybersecurity ISMS (ISO 27001).

Jun 2023 - Present
2 years 2 months

Founder

Ingenieurbüro CSV CSG Computerisierte System Validierung Consulting Services Gruppe

Jun 2023 - Present
2 years 2 months

Lead Auditor

Qualifyze GmbH

Lead auditor for GAMP, GMP, GDP and ISMS.

Jan 2023 - Present
2 years 7 months
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Use of AI / language models to support creating documents, articles, graphics, images, and videos.

Apr 2022 - Present
3 years 4 months
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Online-Trainingsdienstleistung IT-Testing.de®

CSV Academy including GAMP® in its 2nd edition.

Nov 2021 - Present
3 years 9 months
Schübelbach, Switzerland

Managing Partner

IT-Testing.ch GmbH

Business consulting for validation management, project management, quality management, and test management.

Feb 2021 - Aug 2021
7 months
Sumiswald, Switzerland

Qualification Expert

PB Swiss Tools AG

Qualification expert for the outsourced IT infrastructure.

Sep 2020 - Dec 2023
3 years 4 months
Berlin, Germany

IT SME (Subject Matter Expert), Validation SME, CSV SME, Director IT ad interim, Validation Manager & Test Manager

aap Implantate AG

  • IT SME (Subject Matter Expert) for evaluating IT service providers.
  • Validation SME for the BabtecQ migration.
  • CSV SME for the revalidation of proALPHA.
  • Director IT ad interim.
  • Validation Manager & Test Manager.
Sep 2020 - Dec 2020
4 months
Frankfurt, Germany

IT Testing Expert & Test Manager

KION Group AG

Testing of functional, financial, and fiscal IT systems in the operational units in China, India, Australia, and Europe.

Feb 2020 - Apr 2020
3 months
Frankfurt, Germany

IT Testing Expert & Test Manager

KION Group AG

Testing of functional, financial, and fiscal IT systems in the operational units in China, India, Australia, and Europe.

Sep 2017 - Jul 2020
2 years 11 months
Idar-Oberstein, Germany

CSV and Test Expert

BioNTech SE

Test manager, OQ and PQ test script author and tester for an MES including interfaces to LIMS and GUS for producing vaccines for cancer treatment according to GAMP® 5.

Apr 2011 - Mar 2017
6 years
Ingelheim am Rhein, Germany

Quality Assurance Manager, Author

Boehringer Ingelheim GmbH & Co. KG

  • Quality Assurance Manager as a Senior QM Consultant (IT CSV&C Function (Computerized System Validation & Compliance) according to GAMP® 5 in Europe and worldwide.
  • Validation of applications and qualification of IT infrastructures.
  • Worldwide trainer for the internal validation approach (LeVA – Lean Validation Approach).
  • Maintenance and administration of the SAP-based IT document management system.
  • Review of pharma-specific and related IT-specific work instructions and associated templates according to GxP requirements and compliance with 21 CFR Part 11 and Annex 11, including training of staff.
  • Consulting for internal customer projects and external cloud computing service providers, as well as strategic outsourcing of IT infrastructures as cloud services (SAP incl. HANA (IaaS), AS400 (PaaS), and Monitoring (SaaS)).
  • Audit lead for supplier audits.
  • Author of SLC (System Life Cycle) documentation for 4 ERP systems according to compliance requirements (GAMP® 5, GxP).
Jul 2010 - Apr 2011
10 months
Eschborn, Germany

Test Manager, Team Lead and Deputy Project Manager

Commerzbank AG

Non-functional tests of the core business processes regarding the merging of the customer data records of two banks; administration of HP QualityCenter.

Jul 2009 - Apr 2010
10 months
Eschborn, Germany

Test Analyst, Test Manager and Deputy Team Lead

Commerzbank AG

Development of a generic EAI for connecting the corporate customer data as master data to SAP MARK and a CRM system.

May 2008 - Apr 2009
1 year

Managing Partner

IT-Testing.de Beratungsgesellschaft für Projektmanagement und Qualitätssicherung mbH

Head of the 'Business Consulting' division.

Jul 2006 - Nov 2008
2 years 5 months
Frankfurt am Main, Germany

Head of the Requirements Management and Test Management teams, Specialist

Fraport AG

  • Head of the requirements management and test management teams for departure management and resource management including testing, calibration, and simulation based on business processes; functional and non-functional tests according to ISTQB.
  • Specialist in analysis and documentation of process data flows between the systems of the Fraport AG traffic controllers and the German Air Traffic Control (Deutsche Flugsicherung GmbH).
Jun 2004 - May 2005
1 year
Berlin, Germany

Senior QA and Test Manager

Deutsche Post AG

New development and enhancement of the existing POS software for the service division; leading the QA team in the backend area (6 projects).

Jan 2004 - Present
21 years 7 months

Owner

Ingenieurbüro IT-Testing.de®

Business consulting for validation management, project management, quality management, and test management.

Jan 2003 - Dec 2003
1 year
Germany

Senior Consultant

IBM Business Consulting Services GmbH

Senior consultant and test manager, e.g., on projects at Cortal Consors in Nuremberg for the development of a new online finance portal.

Oct 2000 - Dec 2002
2 years 3 months
Germany

Principal Consultant

PricewaterhouseCoopers Unternehmensberatung GmbH

Principal consultant, test manager, and project manager on projects at Infineon (Munich), Bankgesellschaft Berlin, Vodafone (Düsseldorf), and Lufthansa AG (Frankfurt).

Jan 1998 - Sep 2000
2 years 9 months
Frankfurt, Germany

Task Lead and Project Manager

Fraport AG

Task lead, project manager, and test manager on the airside for projects like the development of the Airport Operational Database (AODB), Emergency Information Data (EID), the Year 2000 problem (Y2K), and the marketing of air traffic, passenger, and cargo data.

Feb 1989 - Dec 1997
8 years 11 months

Student Assistant

Various Companies

Student assistant in plant engineering, healthcare, aviation, and IT.

Languages
German
Native
English
Advanced
Education
Apr 1993 - Jan 1998

Technical University Darmstadt

Degreed engineer · Civil Engineering · Darmstadt, Germany · Good

Oct 1988 - Mar 1993

Rheinisch-Westfälische Hochschule

Pre-degreed engineer · Civil Engineering · Aachen, Germany

Certifications & licenses

ISTQB Test Analyst, Advanced Level

ISTQB

ISTQB Test Manager, Advanced Level

ISTQB

ISTQB Certified Tester, Foundation Level

ISTQB

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