Grenzach-Wyhlen, Baden-Württemberg, Germany
passionate, collaborative and result-driven leader with strong QA experience in local and global functions of Pharma and CMO business, acting as or supervision of Qualified/Responsible Persons (FvP) track record of successful achievement of goals and improvements
Accountability for entire Quality System and GMP Compliance of manufacturing site as QA site head Leading a growing team of >100 quality & compliance experts Member of site management team, legal role as Responsible Person (for Import, Wholesale, Foreign Trade) close interactions with customers and authorities
Accountability for QA department "Quality Systems and Validation", ~ 25 employees Successful introduction of an electronic Quality Management System at the site Auditing
Lead of different global Quality & Compliance projects
Accountability for GMP Quality System and Project Portfolio of site ~10 employees Legal roles as Head of Production, Responsible Person for Narcotics & Psychotropics international assignment to support issue management at US site Auditing
End-to-end accountability for supply of analytical Reference Standards at global Roche Pharma and beyond (procurement, synthesis, purification, characterisation and certification, filling, storage, distribution) Heading >30 employees in matrix organisation
Analytical method development and validation, drug substance analytics
Isolation of novel, bioactive molecules, Structure elucidation of natural products