working within FDA, EMA, ISO, GMP, or other regulated manufacturing environments with a strong understanding of quality...
regulatory requirements (e.g., FDA, EMA, ICH) and internal quality standards. Support investigations (OOS, OOT, deviations...
of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures...
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...
-functional group Some knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification...
Experience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related...
platforms Perform method development, qualification, and routine sample testing Apply working knowledge of ICH, FDA, EMA...
in analytical method development, characterization, and qualification/validation Knowledgeable in ICH/FDA/EMA guidelines...
(not required) Opportunity to supervise advanced practice providers (compensated) Utilize EMA / EMR software Position available due to practice...
, and EMA EMR Competitive compensation model with guaranteed base, collections-based upside, comprehensive benefits and CME...