Quality Operation Manager (GMP)
Support Inspection readiness programs across the organization. Regulatory agency inspections (e.g., FDA, EMA...
Support Inspection readiness programs across the organization. Regulatory agency inspections (e.g., FDA, EMA...
supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.). GLP experience a plus. Able to provide...
discipline with 17+ years of related experience Strong knowledge of: cGMP, FDA, EMA, ICH guidelines Experience with: TrackWise...
expectations (FDA, EMA, etc.). Familiarity with Lean Manufacturing, Six Sigma, and continuous improvement tools. Strong...
to close CAPAs on time. Champion Inspection Readiness: Keep practices and data aligned with cGMP, FDA, EMA, EU GMP Annex 1...
. Strong knowledge of pharmaceutical regulatory requirements (ICH guidelines, EMA/FDA regulations, and international standards...
Understanding of GMP quality systems Knowledge of FDA/EMA regulations governing potency assay development Experience...
, commercial, HMO) EClinicalWorks, EMA, or other EMR software Exciting Perks: 40% off products and procedures, as well as the...
if familiar with EMA/ModMed and/or NexTech) 2 years front office experience required Excellent computer and phone skills...
them to meet evolving regulatory and business needs Act as direct liaison with agencies such as the US FDA and EMA, build...