Dr. Thomas Vogelsang

• Quality stewardship and strategie definition from development to discontinuation. SPOC for quality. • Product network quality oversight including risks assessments. • Lead and support quality programs and projects. • Provision of key quality decisions to Senior Management. • Deputy Responsible Person (FvP) (Swissmedic) and Grosshandelbeauftragter (GDP RP) (BfArM).

• Support the Head of Global Quality Management in establishing and maintaining the Quality Management System and HSE in line with Executive Management • Act as the Responsible Person (Fachtechnisch verantwortliche Person) registered with Swissmedic • Act as responsible HSE coordinator for Basilea HQ

• Quality Management (cGMP/ISO 9001) • Batch record review and release of finished products • Deviation management • Change Control management • CAPA management • Management and execution of qualifications and validations incl. CSV and project management • Management of cGMP-documents • Management and execution of internal und external audits • Management of audits with authorities and customers • Contact to customers and authorities • Release of cGMP-documents • cGMP-training

• Line Manager of up to 35 employees / 6 direct reports (Group Leaders) • Responsible for the analysis and release of pharmaceutical raw materials, packing materials and finished products • Stability testing • Analytical development • Method, cleaning and process validation • Various Deputy Functions (Qualified Person/RP/FvP, Head of Quality Assurance, Head of Microbiology and Head of Clean Water Manufacturing)

Organische Chemie Macromolekulare Chemie Analytische Chemie