- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality Systems Lead role ... an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy...a portfolio of ongoing projects.Ability to work with and lead others in a team environment.Experience developing and setting… more
- Formation Bio (New York, NY)
- … quality system, including the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry ... to ensure the consistent production of safe, effective, and high- quality pharmaceutical products. Lead internal and external...thinker, strong leader, and subject matter expert in pharmaceutical quality systems with the ability to design… more
- Tris Pharma (Monmouth Junction, NJ)
- …standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event, ... product quality complaintsEngages in activities to continuously assess and improve quality systems by identifying and proactively resolving quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: The Associate Director, R&D CTMS Operations Lead will lead the business operations team in one or more ... systems /capabilities with the R&D functional area, in adherence to...deliverables are conducted according to the timeline, budget and quality metrics set forth by the study team and… more
- Merck & Co. (South San Francisco, CA)
- …as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also work closely with therapeutic area ... immuno-metabolic, and cardiovascular diseases to enable a robust drug discovery pipelineDrive hit/ lead finding and lead optimization plans in collaboration with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Control Systems ) is responsible for acting as a technical lead and trusted advisor, ensuring high availability, optimal performance, and reliable operation ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...of the Control Systems at API M2-US. This role involves design, integration,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Rapid Clinical Analytics Lead Data Scientist role sits within the Clinical Data...data, CDC Surveys (eg, NHANES) as well as internal systems of record to conduct a diverse range of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of ... label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance… more
- Novo Nordisk Inc. (Durham, NC)
- …preferably in the pharmaceutical industry Demonstrated expertise in Regulations & quality systems (eg, commercial product disposition, DV/CAPA, Change Control, ... processes. Relationships Reports to Manager, QA. Essential Functions Ensure plant systems batch release & relevant quality processes are compliant with… more
- Merck & Co. (North Wales, PA)
- …and initiatives. Serve as a subject matter expert for functional group processes, systems , and regulations driving disclosure quality assurance and compliance . ... and data sharing with external researchers. - The Director, Disclosure Quality & Compliance is responsible for independently leading/executing projects that… more
