- Novo Nordisk Inc. (Plainsboro, NJ)
- …to enable compliance with QMS process requirements across NNI and global as applicable Proactively identifies risks/ quality drift in external vendor and ... to ie team members. Relationship Reports to head of North America Operations Quality Pharmacovigilance Oversight. Maintains positive rapport and working… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and global as applicable Proactively ... ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enable compliance with Deviation process requirements across NNI and global as applicable Develops and executes regular surveillance, follow-up, and reporting ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all ... budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers and other clinical operations staff while… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Global Biologics Operations (GBO) organization is responsible for manufacturing and supplying commercial biologic products that support over ... more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations , the Head of Global Biologics Launch… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies… more
- Merck & Co. (Rahway, NJ)
- …NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily for sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences ... (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The role is...require routine interaction with Partner Groups such as GES ( Global Engineering Services), Facilities Management (FM/GWES) and Original Equipment… more
- Merck & Co. (Durham, NC)
- …Production Operations , Production Scheduling, Safety, Health, Environment and Quality (SHEQ), Safety Procedures, Shift Work, Standards Compliance , Systems ... We work in the local plant connected to our global manufacturing network to ensure the highest quality...& housekeeping walkthroughs, 5S, kaizen events, or any other operations , lean six-sigma, quality , safety or environmental… more
- Merck & Co. (Durham, NC)
- …in equipment validation, process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Specialist performs laboratory testing on a ... Job Description GENERAL SUMMARY :Our company is expanding its global Bacillus Calmette Guerin (BCG) vaccine production by adding an end-to-end laboratory capability… more
- Merck & Co. (Millsboro, DE)
- …Culture, Manufacturing Documentation, Manufacturing Operations , Manufacturing Quality Control, Media Preparation, Process Improvements, Regulatory Compliance ... Job DescriptionOur Manufacturing Operations teams are the people that make our...We work in the local plant linked to our global manufacturing network to ensure the highest quality… more
- Merck & Co. (North Wales, PA)
- …leadership, technical skills, and scientific acumen as part of a global , cross functional team.Job ResponsibilitiesResponsible for leading specific aspects of ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Insmed Incorporated (San Diego, CA)
- …Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...cross functional working groups to identify and mitigate GCP quality and compliance issues.Supports the evaluation and… more
- Merck & Co. (Durham, NC)
- …- Ability to use deep knowledge and expertise in Manufacturing, Technical, and Quality Operations to drive results and business outcomes. End-to-End Mindset - ... Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance :-Achieve … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Global , Regional and Local Leaders. Interacts with other HR colleagues, global colleagues, legal and compliance , employees and hiring managers at all ... global organization in consultation with various departments Solid understanding of global TA operations procedures, guidelines and legal requirements as they… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... for Millennials™, and Best Medium Workplaces™ lists.OverviewLead Analytical Development Operations function to build out the process development support testing… more
- Twist BioScience (South San Francisco, CA)
- …(SDS), product labeling, and SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory ... The Regulatory Operations Specialist is responsible for ensuring the efficient...Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. Collaborate with cross-functional… more
- Eisai, Inc (Exton, PA)
- …profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a scientific team ... of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also responsible to… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …your potential? The Position This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. ... strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries… more
- Merck & Co. (Durham, NC)
- …Company Overview Our company in the United States and Canada, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and ... and an inspiring mission to achieve new milestones in global healthcare. Our Manufacturing Division is a team of...development, management, and growth of our warehousing and logistics operations , both on the main campus as well as… more
