Ensure quality operations comply with global regulatory requirements (e.g., FDA, EMA, PMDA) and internal standards. Support..., enhance risk management practices, and optimize global quality system processes across a global quality organization...
). Strong understanding of GMP/GxP requirements for large molecule commercial reagents as per global agency (e.g., FDA, EMA... will lead a multidisciplinary, global team (including first-line managers and scientists) and collaborate extensively...
/Usability Engineering (HF/UE) principles into the design and development of products within Bayer's global Radiology and Pharma... of brilliant and diverse minds to make a real difference, there's only one choice. Associate Director, Human Factors Engineering...
knowledge of PV regulations: FDA (21 CFR 312.32, 314.80, FAERS), EMA GVP (Modules VI, VII, IX), and ICH E2 (E2A-E2F). Direct... (Big 4 or life sciences consultancies) in PV projects. Involvement in regulatory inspections (FDA/EMA GVP), and audit...
of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale... and safer. We provide our global teams with the resources needed to achieve individual career goals while helping...
relationships. Acts as the primary quality representative for the global supply chain pertaining to external manufacturing business..., Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and PDS&T...
within Global Clinical Affairs, the Senior Clinical Database Developer is responsible for leading the design, development..., and ongoing maintenance of clinical study databases supporting global medical device clinical trials. This role serves...
About Servier With commercial stage products and a promising pipeline, we are Servier Group, a unique global... - MSAT, this global role leads a team of subject matter experts (SMEs) responsible for supporting commercialization...
Senior Engineering Technician Position Summary: Work Schedule: 7pm-7am, Sunday-Tuesday and every other Wednesday... 100% on-site Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development...
and approve system lifecycle documentation generated by project teams to ensure alignment with local SOPs and global regulatory... expectations. Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA...