Grenzach, Baden-Württemberg, Germany
Experienced leader with R&D, Product Management and Quality Operations track record of more than 10 years in the Life Science industry. Master of Business Administration by ESSEC and Mannheim Business School and Ph.D. in Bio-Organic Chemistry.
Leading Environment, Health, Safety and Quality as member of the extended site leadership team. Executing the merger of former EHS and Quality/GMP function to an integrated EHSQ team.
Site Quality Lead with scope QC, QA and QM incl. intenal and supplier audit program and analytical service for waste water treatment plant. Member of the extended site management team. Certification as internal auditor (9001 and 14001). Responsible for GMP-compliance of API manufacturing (ICH Q7), ISO 9001, RSPO, Halal. Implementation of state-of-the-art LIMS and EFfCI ("Cosmetic GMP") standard on site.
Leading total quality management at the Heidelberg site in coordination with global quality strategy. Leading a team of >100 people with the following direct reports: - Head of Quality Assrance (QA) - Head of Quality Control (QC) - Qualified Persons Responsible for strategic extension and to maintain required GMP manufacturing licence (leading communication with authorities) and acknowledged competence of qualified persons (acc. AMG §15). Achieved reorganisation of quality unit, extension of manufacturing license and acknowledgement of qualified persons, implementation of lean management tools (e.g. performance boards) and of LIMS.
Strategic Marketing & Innovation at Mobile Analytical Workflow (MAW) Franchise. Senior Global Product Manager for instruments and consumables with double-digit million P&L accountability. Portfolio strategy and business development for MAW. Implemented MAW innovation strategy within Advanced Analytical business field.
Group leader R&D of Test Strips, Photometry and Microscopy Solutions (according to ISO 13485). Instrument development, project management, coordination of external development partners and suppliers in technical projects. Leading a team of 14 FTEs.