As discussed on the Fisher BioServices blog, GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, […]
About Johannes Gross
As the Director of Quality and Regulatory Affairs, Johannes has responsibility for all regulatory and quality activities performed at all US Fisher BioServices (FBS) sites. This includes ensuring adherence to all applicable regulations and ensuring that all activities on site are performed to the standards set out in the quality management system (QMS).
Johannes Gross has worked within the biotechnology industry since 1985 and has a broad knowledge of regulatory authorities including the FDA, FDA-QSR, Design Control, cGMP, TQM, ISO, CE. Responsible for leading the Quality Assurance function within Fisher BioServices which includes both the Government and Commercial operations. This position ensures the development, maintenance and effective implementation of the Quality System to achieve a superior level of compliance regarding all regulatory, quality and customer-related requirements affiliated with Current Good Manufacturing Practices (cGMP).
•Assures regulatory compliance, operational effectiveness, service outcomes that meet or exceed our customers’ expectations.
•Leads the businesses Quality/Continuous Improvement Program.
•Plans, implements, and reviews all QA/QC policies and procedures and manages the department budget. Manages regulatory and client audits of BioServices operations.
•Supports Sales, Client Services, and Marketing during customer interactions and in the preparation and review of proposals.
•Manages the departmental personnel development and serves on the Fisher BioServices Executive Leadership Team (ELT).