OVERVIEW
FOCUS AREAS
EXPERTISE
– Data & Technology Roadmap design & deliverables (OKR, metrics/KPIs, strategy, use cases, requirements, governance, people & capabilities, architecture, systems & compliance)
– CSV & CSA (GAMP5, US FDA 21 CFR p11, EU Annex 11 & 15)
– Information Security (ISO/IEC 27001 & 27002)
– BCP & TTE (ISO 22301)
– Data Integrity (“ALCOA++”)
– IT GxP Due Diligence assessments, Audits, Mitigation/Remediation planning & execution.
– RfI, RfP, RfQ planning of ERP, MES, Historian, LIMS, WMS, PAT, DCS, SCADA for plants, labs, warehouses.
- Data & Technology Strategy
- ICT Management Systems (e.g. CoBIT, ISA95, ITIL)
- ICT Law (e.g. EU GDPR, EU Data Acts [DMA, DSA, AIA] )
- Program- & Project Management
- M&A, Divestitures change management
Throughout his executive career with PPG industries (Glas-Technology) as well as the Johnson & Johnson corporation (J&J) Michael held leadership positions in Technology Services, The Janssen Pharmaceutical companies of J&J – budget accountability (OpEx) of teams of 100 internal associates, operating the IT of the global manufacturing network (25 plants), supporting annual sales of US $$bn –, Cilag GmbH International, J&J Medical Ltd, J&J Medical GmbH, and Ethicon GmbH & Co. KG, which includes operating under strict quality (FDA), financial (Sarbanes & Oxley Act US), healthcare compliance, and data privacy (EU GDPR etc.) regulations.
Leveraging extensive experience in these areas of international expertise, Michael is a valuable advisor for any organisation on their mission to achieve transformational changes either in optimisation of performance or growth of operating margins. This he achieves through leveraging vision and mission as well as people- & resource-focused and result-driven OKR’s (priorities, goals & objectives, and time-tables).
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Michael has earned a B.Sc. in Business Administration (IT/Computer Sciences) from the University of Applied Sciences, Pforzheim, Germany, and an LL.M. with Merit in Information Technology Law from the University of Edinburgh Law School.
Michael has Diplomas in General Management and Organisational Leadership (Executive Programs), and is certified in Process Excellence/Six Sigma (Green Belt) and Computer System Validation (GAMP).
He is Keynote speaker at international Bio-/Life-Sciences industry conferences, and a Visiting lecturer at the Hamburg University of Applied Sciences, Germany.
Michael is fluent in both English and German.
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Leadership positions:
– ELIQUENT Life Sciences – Partner & Principal Executive Consultant, IT/CSV/GAMP/Data Integrity/Supply Chain/Operations (2021-Present)
– Johnson & Johnson – Global Head, Sr. Director, Technology (2018-2020)
– Janssen (J&J) – Global Head, Technology Strategy & Operations. (2017-2018)
– Janssen (J&J) – WW VP, IT JSC Manufacturing, Sourcing, Tech Ops (2012-2016)
– Johnson & Johnson Consumer Healthcare – EMEA Sr. IT Director, Supply Chain (2011 – 2012)
– Johnson & Johnson Medical Devices – Reg. IT Director, DACH & Nordics (2009 – 2011)
– Johnson & Johnson Medical Devices – Reg. IT Director, Iberia, BeNeLux & TMEA (2007 – 2009)
Extensive experience:
– IT strategy, Governance & Compliance.
– Global operations in supply chain, manufacturing, quality, shared services, and business process improvement.
– Transformational missions in both optimization of performance & growth of operating margins.
– Risk Management and Change/Transformation management.
Areas of responsibility include:
– Design & delivery of the Technology Strategy
– Digital Roadmap – Design & deliverables incl. organisation, governance, data architecture, supporting systems & compliance
– Computer System Validation & Assurance (cGxP: US FDA 21 CFR p11; EU Annex 11), Data Integrity (“ALCOA+”)
– Due Diligence assessments, audits, mitigation/remediation planning & execution.
– Planning (RfI, RfP, RfQ) of ERP, MES, Historian, LIMS, WMS, PAT, DCS, SCADA for plants, labs, warehouses.
– Assessments & audits in relation to Supply Chain, Manufacturing, Quality Management, OT & IT performance.
– Interim Operations, Organizational Change, Program & Project Management.
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