Nuremberg, Bavaria, Germany
A Quality professional with extensive experience of: •Primary and secondary manufacture using groundbreaking technologies. •Regulatory inspections by the MHRA (GMP, GCP, GPvP & GLPMA), FDA (GMP), Regierung Oberfranken (Germany GMP) and Health Canada (GMP). •Regulatory affairs in relation to generics, clinical trials, biotechnology & radiopharmaceutical products. •Project management, including due diligence, of critical quality and business projects. •Leadership within the quality department and across organisations. Specialties: A recognised expert on: •GXP Quality Systems design, implementation and management. •Auditing and audit management systems. •Training and training management. •Establishing and leading teams of empowered Quality professionals.
Leading the Quality Assurance, Quality Control, Pharmacovigilance and Regulatory Affaires groups for Torrent Pharma GmbH and associated brands, including Heumann Pharma GmbH & co. Generica KG, in Europe.
Leading the Global R&D, Pharmacovigilance & Regulatory Quality Assurance teams for Elanco Animal Health. A member of the R&D and Quality leadership teams, responsible for R&D Quality Assurance accross the full veterinary product portfolio, including small molecules, feed additives and vaccines. Establishing an R&D Quality organization to develop and maintain the strategies, governance, processes and controls necessary for ensuring appropriate regulatory compliance, across multiple regulatory markets (i.e. FDA; EMEA; MHRA) and lead the design, implementation and on-going maintenance of the global approach to compliance for the Pharmacovigilance & Regulatory functions.
Leading the Global Development QA Operations group of Sandoz International GmbH. Responsible for Sandoz Development Centre Quality functions worldwide. Supporting global development projects, Quality Culture and Quality teams for the development of high quality, differentiated, generic medicines.
Director & Ordinary Board Member of RQA sitting on the Good Manufacturing Practice, Finance, Outreach and Medical Devices committees. RQA represent Quality professionals working in regulated scientific research and development, including GLP, GCP, GMP, GPvP, Animal Health and Medical devices, and provide training in Quality topics. Co-author of the BARQA "Quality Systems Handbook" supporting academic and NHS groups to establish thier Quality Systems.
Head of the Quality/Validation/Compliance unit at an innovative cross-GXP research unit. The operations covered include basic scientific research, Pre-clinical testing, GCP Clinical trials (Methodology & Phase I-IV) and GMP manufacture of sterile radiopharmaceuticals. I was responsible for establishing research quality practices within the framework of GSKs Quality management System. I was co-author of the GSK Clinical Quality Handbook and had QA responsibility for all early phase manufacturing in third parties, including extemporaneous compounding.
Facility set-up and establishment of the Quality Management System for the GSK Clinical Imaging Centre. The operations covered include basic R&D, Pre-clinical testing, Clinical trials and GMP manufacture of sterile radiopharmaceuticals.