Senior Pharmaceutical Quality professional with 25+ years of strategic quality leadership across GCP and GVP domains, operating through Pharma Quality Management AB.
Work centers on QMS transformation aligned with ICH E6(R3) and the EU Clinical Trial Regulation (CTR), FDA requirements, Data Integrity, and end-to-end inspection-readiness programming for biotech and small-to-mid-size pharma organisations.
Proven experience in designing and embedding scalable, fit-for-purpose risk-based quality management frameworks, working closely with senior leaders across Clinical Operations, Pharmacovigilance, Data Management, Regulatory Affairs and vendor governance.
