as the primary host and subject matter expert (SME) representative during regulatory (FDA, EMA) and client inspections...
Products and processes meet the U.S. FDA, Health Canada, European Medicines Agency (EMA), and ICH (International Council... and EMA regulatory requirements. Demonstrated experience leading CAPA and Change Review Boards, internal audits...
—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through...
, cleaner, and safer. As part of the Supplier Quality Group, you will help maintain compliance with FDA, EMA, and other cGMP... compliant with FDA, EMA, and other cGMP regulatory requirements, as well as client expectations. Oversee and coordinate...
- Strong knowledge of GMP, FDA, EMA, and other applicable regulatory requirements and industry standards - Proficiency with CMMS (e.g...
, cell & gene therapy, etc.) Basic understanding of cGMP principles and regulatory requirements (FDA, EMA...
preparation for and management of global regulatory inspections (e.g., FDA, EMA, MHRA) Coordinate responses to inspection...
, ICH, EMA). Experience supporting regulatory (i.e. FDA) inspections and audits in front or back room with successful outcomes...
directly in audit and inspection readiness (FDA, EMA), serving as a technical subject matter expert for laboratory analysis...
, and safer. Responsibilities Support site inspection readiness activities to ensure ongoing compliance with FDA, EMA... environment. Strong knowledge of cGMP and applicable regulatory requirements, including FDA and EMA expectations. Hands...