Principal Consultant Data Integrity, Data Governance & AI/ML Validation | Life Sciences & Pharma

Data Integrity & Data Governance
Extensive expertise in Data Integrity and Data Governance for pharmaceutical and life sciences organizations, including development of frameworks, SOPs, policies, risk assessments, audit trail reviews, and training materials aligned with GMP, GCP, and international regulatory requirements.

AI/ML Validation in GxP Environments
Deep knowledge in the validation of AI and Machine Learning models within regulated GxP environments, including development of validation strategies, template packages, stakeholder workshops, and alignment with FDA, EMA, and USP expectations.

Computer System Validation (CSV/CSA)
Proven track record in Computer System Validation and Computer Software Assurance, covering CSV strategy, cloud compliance, qualification and validation frameworks, and project leadership for CSV initiatives in pharmaceutical manufacturing and laboratory settings.

GMP & GCP Compliance
Comprehensive understanding of GMP and GCP compliance requirements, including audits, quality assessments, and regulatory authority engagement for pharmaceutical and life sciences organizations.

Quality Management Systems
Experience implementing and auditing Quality Management Systems in accordance with ISO 13485, ISO 9001, cGMP, and international guidelines, including interim QA leadership roles.

Training & Speaking
Active trainer and international speaker at major industry conferences such as PDA, PharmaCongress, ECA PharmaLab Congress, and KENX Validation University, covering topics including Data Integrity, AI/ML Validation, and GMP compliance.

Regulatory Affairs & Industry Engagement
Member of the PDA Scientific Advisory Board (RAQAB), Regulatory Authority Engagement Liaison for EMA Quality Working Party, and Co-Lead of the DI/DG Interest Group, contributing to regulatory guidance and industry standards.

Data Science & Machine Learning
Certified in Data Science and Machine Learning (HarvardX), with practical application in developing ML validation strategies, anomaly detection frameworks, and AI/ML implementation approaches in regulated environments.

Physics & Medical Imaging Research
Academic background in Physics with a doctoral thesis on Advanced Cardiac Magnetic Resonance Imaging with Hyperpolarized 13C Acetate and Pyruvate, conducted at Technische Universität München and GE Global Research Europe.