, and proactively mitigate technical and supply chain risks Ensure compliance with cGMP, ICH guidelines, and global regulatory..., IMPDs, NDAs, and future BLAs/MAAs). Serve as CMC technical lead in regulatory interactions with FDA, EMA, and other health...
100% on-site (Madison, WI) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO...). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities...
field (e.g., Life Sciences, Engineering, Quality Assurance, etc.) 1-5 years of experience in quality assurance... requirements (FDA, EMA, ICH). Experience with quality management systems and GDP practices in a GMP facility. Experience in cell...
/vessels, CIP skids, etc.Ensure CQV documentation and testing meet GMP, FDA, EMA, and global regulatory expectations.... Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team...
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare... and lyophilization process engineering for parenteral packaging and Lilly's combination products. The candidate will drive development...
100% on-site (Madison, WI) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO...). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities...
, Change Control, Document Management, GMP training, quality agreements process, complaints system, and global J&J standard...'s degree in a scientific or engineering discipline is required. A minimum of 6 years’ experience working within the biological...
, electronic engineering, physics, etc). Global experience and a nuanced understanding of international regulatory landscapes..., Regulatory, and Validation Support Design validation studies following FDA, EMA, or MDR-aligned frameworks, including GCP/GCLP...
) in support of a global region (i.e., Americas, EMA or Asia/Pacific.) Organized with attention to detail. Excellent analytical... in one or two functional areas (i.e., Operations, Finance, Order Management, Procurement, Engineering, Human Resources or Payroll...
with ICH, FDA, EMA, and other global guidelines. Health Authority Interactions:Serve as the primary point of contact for CMC... within Regulatory Affairs responsible for the global regulatory strategy and execution related to the pharmaceutical quality...