of FDA, EMA, and global GMP regulations including 21 CFR Parts 210/211, ICH guidelines Proficiency with quality management... Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing...
QA Systems Manager – eQMS & CSV Projects: This will be a global position leading and supporting the implementation.... Provide regular updates to Senior Management and key stakeholders including consolidated site-specific and global metrics...
. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital... regulatory requirements of various Health Authorities (e.g., FDA, EMA, MHRA). YOUR ROLE Leads and manages QC Incoming...
a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers... to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual...
. If this is your profile, we want to hear from you. The Director, Global Labeling is responsible for the leadership and oversight of the... Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling operations...
engineering, chemical engineering, biochemistry, or pharmaceutical sciences, with at least 12+ years of experience... and working with global teams and external CDMO's Knowledge of Quality by Design principles, cGMP, and CMC requirements...
compliance and training systems. Ensure compliance with global regulatory requirements such as FDA, EMA, ISO 13485, GMP...’s pharmaceutical and medical device operations. This role ensures adherence to global regulatory requirements, industry standards...
Life Ensure compliance with cGMP, ISO 9001, and applicable global regulatory requirements (FDA, EMA, etc.) Maintain..., NY site is a key Thermo Fisher Scientific Global Label Services location, specializing in clinical trial labeling design...
(EMA), other applicable jurisdictional authority) and audits of the Foundation. Validation Execution and Documentation.... QUALIFICATIONS Bachelor’s degree in a technical or scientific discipline (e.g., Computer Science, Engineering, Biology). A minimum...
a global team of MSAT E2E Product Leads who represent MSAT in Strategic Operations Teams (SOTs) and provide cross-functional... alignment and performance monitoring between global MSAT leadership, site MSAT teams, and cross-functional partners in Quality...