- Novo Nordisk Inc. (Durham, NC)
- …approve external calibration service suppliers. Relationships Reports to the Manager , Metrology. Essential Functions Ensure correct calibration standards are ... available Create, approve & manage calibration specifications & methods, in area of responsibility Configure SAP maintenance plans, scheduling & task lists in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within therapeutic area of responsibility Chairmanship/membership of the NN cross-functional safety committees Participate as a member of the first safety ... for patients. The Position This leadership role is accountable for developing the safety strategy, major safety deliverables for assigned programs within the US… more
- Novo Nordisk Inc. (Durham, NC)
- …Monday - Thursday working 10hr day shift schedule. Relationships Reports to Manager , QA. Essential Functions Ensures site compliance with Regulations, ISO standards, ... analysis Participates in process confirmations & Go Look Sees Follow all safety & environmental requirements in the performance of duties Other accountabilities, as… more
- Novo Nordisk Inc. (Durham, NC)
- …Lead team in successful execution of QC and Stability activities based on assigned area of accountability Coordinate with the responsible manager and other teams ... is responsible for supervising QC activities and personnel within assigned area of accountability. Responsible for ensuring testing of in-process, release, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Laboratory Compliance Manager role is an exempt level position with responsibilities...meetingsCollaborate with cross functional team (Investigation Management and Functional Area Owners) to align on root cause, corrections, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... ready to maximize your potential with us? The PositionThe Manager - Market Access Insights is charged with assessing...impacting markets and organized customers Collaborate with Franchise and Area Insights & Analytics teams, as well as Marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … procedures, cGMPs, and SOPs. Responsibilities Maintain compliance with cGMP, safety standards and good housekeeping standardsAssist Operations Manager in ... Position Summary The Assistant Operations Manager will work under the direction of the Operations Manager to provide oversight and administrative support while… more
- Merck & Co. (Durham, NC)
- …quality-driven decision making, and coaching of the team (eg documentation, housekeeping, area 5S, etc.)Participate as an SME in safety /regulatory audits (ie ... 3-weeks rotation which includes a weekend every three weeks.The role of Operations Manager at our company is a manufacturing leadership role. The individual in this… more
- Merck & Co. (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to ... through current Quality Systems (eg, CLUE and SAP).Support and maintain a " Safety First", " Quality Always" environment with participation in Site GEMBAs for… more
- Twist BioScience (South San Francisco, CA)
- …outside vendors to complete requests as needed, and at the direction of manager Manage waste streams through-out the facility (lab waste, biohazardous waste and ... of site to ensure compliance with local health and safety regulations Model company safety policies and...level response Maintain professional appearance of building lobby, reception area , and food service area Perform set-ups… more
- Novo Nordisk Inc. (Durham, NC)
- …training for lower-level peers. Demonstrate subject matter expertise in assigned area . Provide process solutions for moderate to high complexity issues. Serve ... includes ensuring that relevant actions are carried out and completed. Relationships Manager . The role is responsible for collaborating with stakeholders related to… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific integrity; regulatory and ... approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interactions. Independently manage interactions with clinical leads, data management, safety , regulatory, and QA team members, both internally and externally. ... metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points. Collaborate with other functions (at CRO or internally) to… more
- Novo Nordisk Inc. (Durham, NC)
- …with every Friday and Saturday along with Sundays off. Relationships Project Director/ Manager . Essential Functions Serve as the training expert in assigned area ... training to address competency gaps Conduct &/or coordinate training for partnered area Assist as a subject matter expert (SME) in application of established… more
- Merck & Co. (Durham, NC)
- …by policies, procedures and business plan; receives limited guidance from manager .Provides planning and scheduling guidance to mechanics, technicians and colleagues ... and maintenance activities are completed in accordance with established safety , GMP, and calibration/maintenance proceduresUpdate maintenance procedures to ensure… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The SQE Manager , QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring ... of pharmaceutical production in compliance with all CFR, USP, cGMPs, and SOPs. SQE Manager , QA Compliance will rely on experience and judgment to plan and accomplish… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Developer II will have a primary emphasis on one area at a time, but example areas may include:...such as Azure DevOps. Relationships Reports directly to the manager of Global Security Operations - Security Analytics and… more
- Fidelity Investments (Boston, MA)
- …with the deep expertise necessary to build the future of finance. As a Senior Manager - Product Delivery Analysis on the FDA Product Delivery team you would have the ... structure, you will function both independently and as a manager of Business Analysts. Your contributions will enable your...contributions will enable your team to develop in their area of expertise and ensure alignment on the work… more
