with FDA, EMA, WHO, and global regulatory expectations. The Director, QC is a key member of Site Quality Management..., contamination control strategy (CCS), and alignment with current FDA/EMA expectations for aseptic and biologics manufacturing...
in analytical method development, characterization, and qualification/validation Knowledgeable in ICH/FDA/EMA guidelines...
with regulatory standards (e.g., GMP, FDA, EMA), accrediting organizations (e.g., FACT) and industry best practices. Drive innovation... requirements, including FDA, EMA, and other global and state health authorities, for the development and manufacturing of cell...
working within FDA, EMA, ISO, GMP, or other regulated manufacturing environments with a strong understanding of quality...
, and closeout Strong working knowledge of FDA, EMA, MHRA, ICH/GCP, global clinical trial regulations, quality systems, inspection...
Experience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related...
Part 11, EMA Annex 11, and core quality workflows. Must possess a clear understanding of the systems validation process...
equipped, EMA-enabled clinic. The role does not require supervision of advanced practice providers, allowing you to stay...
, and EMA EMR Competitive compensation model with guaranteed base, collections-based upside, comprehensive benefits and CME...
and EMA / EMR Competitive compensation, comprehensive benefits, loan repayment and partnership potential Location...