Sealand Region, Denmark
Senior Quality Manager at Takeda Pharma A/S
Pharmaceuticals
Education
The Copenhagen School of Design and Technology (KEA) 2010 — 2011
Project management
NLP Huset 2003 — 2003
NLP Practitioner, NLP
Pathfinder Leadership Program 2000 — 2001
Leadership
Danmarks Tekniske Universitet 1984 — 1986
PhD, Analytical chemistry
Danmarks Tekniske Universitet 1978 — 1984
MSc, Chemical engineering
Ballerup Gymnasium 1975 — 1978
Student, Matematisk-Fysisk linje
Experience
Takeda Pharma A/S April 2012 - Present
Jamboree Denmark 2012 February 2011 - September 2012
The Green Girl Guides/De grønne pigespejdere February 2008 - May 2012
Eurofins Pharma A/S February 2012 - April 2012
Genmab August 2011 - February 2012
Symphogen May 2007 - October 2010
Danish Medical Devices Certification, DGM May 2007 - March 2009
Danish Medical Devices Certification, DGM January 2004 - April 2007
Novo Nordisk Servicepartner A/S 1999 - 2003
Novo Nordisk A/S 1993 - 1999
Skills
FDA, LIMS, Root Cause Analysis, GxP, ISO 13485, CRO, Aseptic Processing, Pharmaceutical Industry, Supplier Quality, TQM, Continuous Improvement, GLP, Manufacturing, Lean Manufacturing, Process Improvement, Iso 9000, Quality System, Change Control, Computer System..., ISO 14971, Medical Devices, Regulatory Affairs, Regulatory Submissions, Calibration, Regulatory Requirements, Quality Control, Quality Systems, GMP, 21 CFR Part 11, Pharmaceuticals, Quality Assurance, Validation, Biopharmaceuticals, Biotechnology, V&V, Quality Management, Sop, ISO 17025, Technology Transfer, Cross-functional Team..., ISO, Software Documentation, GAMP, GCP, Clinical Trials, cGMP, Process Validation, Quality Auditing, SOP, CAPA