- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality plan with specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by ... procedures through partnership with stakeholders and QA line functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored ... Global review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of company sponsored studies review… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...based in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt… more
- Merck & Co. (Durham, NC)
- …of the Quality System Model and relationships across its componentsUnderstands quality systems relevance and importance when developing quality policies, ... grasping pushing and pullingAbility to travel WORKING RELATIONSHIPS: Reports to Quality Manager Interacts with employees within own department Frequent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... is responsible for providing project management, drug development expertise to Global Project Teams including strategic development and execution of an integrated… more
- Merck & Co. (Rahway, NJ)
- …challenges and issues to TA Head/CRD Clinical Research Director/CCQM Country Clinical Quality Manager and or CTT Clinical Trial Team-(as appropriate).Identifies ... manager and/or functional vendor and internal management as-needed.Performs Quality control visits as required.Leads local study teams to high performance:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner ... supporting GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and... global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... suggest and collaborate with Financial Disbursement team members and global colleagues to implement continuous improvement opportunities, review issues log,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …high quality deliverables to support drug development processes and global submissions as required for clinical trials. These include developing and validating ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is… more
- Merck & Co. (Durham, NC)
- …the selected individual must become proficient in the use of manufacturing systems and knowledgeable of site procedures to resolve process/equipment issues, minimize ... downtime, and ensure product quality .- This role actively supports, participates, and embraces an inclusive team culture including significant interaction with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in Raritan, NJ. Role Overview This position represents a critical ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...incorporated with an automation platform that integrates with MES systems in cGMP manufacturing operations. This effort will extend… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... of raw materials, components and services consistent with specified levels of quality , delivery, price and total cost. This position will support the Associate… more
- Catalent (St. Petersburg, FL)
- …responsibility for Quality aspects including but not limited to Quality Systems , Finished Product Batch Release, Training, Internal/External Audits, ... safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality...of bachelor's degree, a minimum of 5 years of Quality or IT role supporting GxP systems … more
- Catalent (St. Petersburg, FL)
- …within at Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch ... Manager , QA (Product Development)Position SummaryThe Quality ...support to internal, client, and regulatory audits.Engage in monitoring quality systems to maintain awareness and audit/inspection… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneously Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties ... in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role… more
- Catalent (St. Petersburg, FL)
- …within at Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch ... QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... data services they provide to support drug development processes and global submissions.This position provides expertise within Data Management by partnering with… more
- Lundbeck (Chicago, IL)
- …be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative ... on our journey of growth! As an Area Sales Manager (ASM) you will be responsible for leading, developing,...Knowing the Business Guides the identification of local market systems of care, patient flow, reimbursement, and provides innovation… more
