Functional Skills
Quality Management
Business Operations
Quality Assurance
Project Management
Data Science
Cybersecurity
Digital Transformation
Regulatory Compliance
Statistical Analysis
Clinical Research
Good Clinical Practice (GCP)
Finance Transformation
Compliance and risk
Agile Software Development
Innovation Management
Software Skills
Miro
SAS
Smartsheet
Microsoft Office
Spark
Veeva Vault
Certifications
PSM IProfessional Scrum Master I
PMPProject Management Professional
Sector Experience
Business Services
Life Sciences & Pharma
Technology
Experience
Klaschka & Co
Management Consulting
Management Consultant
1/2015 - Present
R&D GRC & Policy Advisor, IT Project Lead, Johnson&Johnson/IM, USA (2021 – 2022)
• Led the successful rescue of a first-of-its-kind RWD/RWE platform, protecting a US$10M pivotal investment for Data Science in R&D/IT Advanced Computing.
• Provided expert policy and governance advisory on Cybersecurity, Privacy, and AI for Johnson & Johnson globally.
Chief Operating Officer, RegASK, Singapore/USA (2019)
• Developed 'RegTech' SaaS products to deliver digitally augmented (AI, ML, NLP) compliance services B2B for product expansion into foreign markets (APAC, EU, MENA, LATAM).
• Stabilized global business operations with full P&L accountability and spearheaded compliance and organizational maturity.
Program Director and Startup Mentor, BAYER, USA/UK/Germany (2016-2017)
• Trained pre-launch customer discovery, digital transformation, SaaS product development.
• Led the successful rescue of a first-of-its-kind RWD/RWE platform, protecting a US$10M pivotal investment for Data Science in R&D/IT Advanced Computing.
• Provided expert policy and governance advisory on Cybersecurity, Privacy, and AI for Johnson & Johnson globally.
Chief Operating Officer, RegASK, Singapore/USA (2019)
• Developed 'RegTech' SaaS products to deliver digitally augmented (AI, ML, NLP) compliance services B2B for product expansion into foreign markets (APAC, EU, MENA, LATAM).
• Stabilized global business operations with full P&L accountability and spearheaded compliance and organizational maturity.
Program Director and Startup Mentor, BAYER, USA/UK/Germany (2016-2017)
• Trained pre-launch customer discovery, digital transformation, SaaS product development.
Scimitar Inc.
Management Consulting
Principal, Senior Management Consultant
1/2021 - 6/2025
• Leading strategic operational initiatives for innovative life science companies, leading teams focusing on enhancing operations, streamlining development processes, and achieving regulatory compliance for biopharmaceutical and biotechnology clients.
• Drove strategic, transformative initiatives and enhanced QMS capabilities in life science companies, optimizing operations, streamlining development, and ensuring regulatory compliance for pharmaceutical and life sciences clients.
• Managed teams to enhance QMS capabilities, inspection readiness, and training.
• Led tech transfer team to internalize formerly CMO-outsourced cGMP QC test methods.
• Led strategic transformations in Clinical Operations, Quality, and Regulatory for major biopharmaceutical firms, guiding and implementing cross-functional change.
• Drove strategic, transformative initiatives and enhanced QMS capabilities in life science companies, optimizing operations, streamlining development, and ensuring regulatory compliance for pharmaceutical and life sciences clients.
• Managed teams to enhance QMS capabilities, inspection readiness, and training.
• Led tech transfer team to internalize formerly CMO-outsourced cGMP QC test methods.
• Led strategic transformations in Clinical Operations, Quality, and Regulatory for major biopharmaceutical firms, guiding and implementing cross-functional change.
Boehringer Ingelheim
Other
Regulatory Compliance Officer
1/2005 - 12/2014
• Safeguarded regulatory compliance and proactive GxP inspection readiness of FDA-led inspections in the Medicine Division and successfully prevented any significant findings.
• Developed, harmonized, and implemented global and GCP policies and SOPs, QMS and CAPA, Lean Validation, and ICH for effective quality assurance across sites worldwide.
• Expert contributor to international quality standard development incl. MedDRA, ICH, HL7.
• Co-authored the Drug Information Association's (DIA) PEACH quality guideline "Computerized Systems in Clinical Research, Current Data Quality and Data Integrity Concepts".
• Developed, harmonized, and implemented global and GCP policies and SOPs, QMS and CAPA, Lean Validation, and ICH for effective quality assurance across sites worldwide.
• Expert contributor to international quality standard development incl. MedDRA, ICH, HL7.
• Co-authored the Drug Information Association's (DIA) PEACH quality guideline "Computerized Systems in Clinical Research, Current Data Quality and Data Integrity Concepts".