30 years of experience in Biopharmaceutical Companies/CDMO in site and global leadership roles (Lonza, Celgene, BMS, CSL Behring).
Result driven, innovative, collaborative and agile leader, with passion for connecting strategy with execution, who builds strong, cross-functional and diverse teams that deliver results with a shared purpose and creates a culture of inclusion and trust. Works across organizational and multi-cultural boundaries; has successfully implemented globally, across sites and functions (US, EU, APAC), new or advanced robust standardized processes such as Quality Risk Management (QRM), Internal Auditing.

22 years of Quality Assurance roles covering strategic and operational areas. Highly experienced in Quality Risk Management (QRM), Health Authority inspection management, Internal auditing and implementation of various quality systems on site level and globally (EU, US, APAC). At Celgene providing quality oversight for the outsourced services “Fill Finish” of lyophilized products and introduction of risk-based concepts for external manufacturing oversight and working globally in QRM (Operational Excellence and Quality). Currently at CSL Behring leading a team with global responsibility for GXP QRM Process and Governance and various Compliance Processes (design, implementation, and governance), Strong Advocate of Quality Management Maturity (QMM) and risk informed/ data driven decision making.
8 years in Biotechnology R&D and Biopharmaceutical Operations with direct experience in laboratory and manufacturing, managing successful product tech transfer from lab qualification/process validation to commercial production for the first commercial cGMP API in the Biotech plant at Lonza as project leader.

In Leadership roles in the Parenteral Drug Association (PDA), a non-profit organization and the leading global provider of science, technology, and regulatory information: Vice Chair of RAQAB (Regulatory Affairs and Quality Advisory Board – reporting into PDA’s Board of Directors), member of QMM Task Force and leader of various PDA groups such as Quality Systems, Quality Risk Management and Taskforce on Remote Audits and Inspections.