- Legend Biotech USA, Inc. (Raritan, NJ)
- …tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Review change controls, SOPs, and other documentation.Require minimal ... Part 11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems .Familiarity with core Quality Management System processes.Strong written and… more
- Genmab (NJ)
- …ultimate objective of data quality and consistency across programs and systems . Responsibilities Develops and implements company Study Data Tabulation Model (SDTM) ... When you join Genmab, you're joining a culture that supports your physical, financial , social, and emotional wellness. Within the first year, regular full-time US… more
- Novo Nordisk Inc. (Boulder, CO)
- …serves as the leading expert in quality, compliance, and quality management systems (QMS). Provide direction & coordinate the Quality organization activities to ... & development planning, talent recruitment/selection, managing employee relations, overseeing financial matters and driving continuous process improvement & projects… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …allocations, strategic shifts, or major collaborations that have substantial financial or long-term implications.RequirementsA minimum of a bachelor's degree in ... a Pharmaceutical / GMP facility experience preferred.Computerized maintenance management systems (CMMS)Building Automation System (BAS) and Environmental Monitoring System… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the supplier qualification program, including management of the electronic systems for this program.Work with External Quality and other internal functions ... management and leadership experience is required.Experience working with quality systems is required.Extensive knowledge of chemical, biochemical and microbiological… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OOS monitoring and trending program)Contribute to developing and/or improvements to quality systems in support of global implementation of changes (eg, process and ... in developing, writing and approving technical documents.Experience with Quality systems (Change control, investigations, LIMs, etc.).Extensive technical writing experience.Knowledge… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production ... CAR-T manufacturing or cell processing.Ability to identify/remediate gaps in processes or systems .Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems .Knowledge of cGMP regulations ... industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …processes, GxP standards, and regulatory requirements.Maintain SAP/Ariba or other ERP systems for PO creation, supplier master data, invoice resolution, and spend ... capital projects or large-scale facility operations is an advantage.Proficient in ERP systems such as SAP (preferred), Oracle, or Coupa.Advanced skills in Microsoft… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …SAP and/or Oracle.Technologically savvy with the ability to quickly adopt new systems and processes. Proficient in Excel (Pivot Tables and Advanced Analytics), Power ... BI/Tableau, Word, Visio.Hands on experience with ERP/MRP systems (SAP S4 Hana, Anaplan, Kinaxis Rapid Response, Binocs preferred) and advanced planning… more
