- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics. - Cross-functional and Global Team ... specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs ...as applicable. Support MA/PV health authority inspections with adequate systems and process support, including facilitation of… more
- Merck & Co. (Durham, NC)
- …of the Quality System Model and relationships across its componentsUnderstands quality systems relevance and importance when developing quality policies, ... quality and timely resolution of issuesUtilizes monitoring, performance tools and systems to ensure product quality , drive Right First Time and compliance… 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 ... and Medical Access/Expanded Access Program (MAP)/(EAP)Support the oversight of the overall global oncology review process of PhIV company sponsored studies per… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plans and competitiveness (COGs reduction/TAT/OOS reduction), global investigations, global metrics reporting and systems Co-Facilitates complex global ... (ie. reduce TAT) to maintain competitive advantage Develops Data Analytics & Global Reporting structure and identifies appropriate business systems and tools… more
- Merck & Co. (Rahway, NJ)
- …procedures (SOPs), and will review and approve related deliverables. In addition, the Systems Coordinator will assist with maintaining data quality within our ... Job DescriptionJob Description: The Scientific Communications and Information Sciences (SCIS) Systems Coordinator is a project and system management role within SCIS… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration with the CRO and the study team. Oversee the site qualification process .Monitor clinical trial performance and quality metrics and share with study ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data ... 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …of industry regulatory changes as it applies to CSV Perform assigned Quality Systems activities including Document Management system, Change Control, Deviations, ... are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product...position is to provide subject matter expertise in Computer Systems Validation, process improvement, and IT compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …flow of documents in order to meet submission timelines. The Director will develop the process , tools and systems needed to build a core dossier for global ... 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… more
- Merck & Co. (Rahway, NJ)
- …develop and / or improve Third Party/Supplier relationshipsKnowledge of Finance, Regulatory/ Quality , Privacy and Legal expectations for Global Procurement NOTICE ... Job DescriptionPosition Description: Associate Director, SD&PM Third Party Risk Systems & Governance Supplier Development & Performance Management (SD&PM)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …access to any systems used to support audits/inspections. Provide support to quality systems team, ad hoc, for activities such as annual product review, ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Requirements A… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director, PMO People & Process LeadGlobal Project and Alliance Management (GPAM) sits in the Research & Development organization at our ... Research & Development division.The Associate Director, PMO People & Process Lead, is a unique role that will be...of how our clients navigate business processes and enabling systems to deliver their job responsibilities. In this role,… more
- Catalent (Manassas, VA)
- …years of experience in regulated environment is required. Knowledge of GMP and Quality systems ; Ability to read and follow documents (Standard Operating ... POSITION SUMMARYThe Quality Assurance Specialist I is responsible for inspection...job responsibilities; Resolve any problem related to the production process under their capabilitiesl Collaborate with production employees and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager, Process Engineer- Consultant as part of the Global MSAT team based in ... NJ. Role Overview This position represents a critical technical role supporting process automation efforts within the global MSAT organization. This individual… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed ... aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external… more
- Merck & Co. (Rahway, NJ)
- …technical mentorship.Experience with Potent Compound processing and containment systems (eg, isolators).Experience with Quality systemsExperience interacting ... with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems , etc.Experience working in an environment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working within an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems . Knowledge ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...of multiple myeloma. Legend Biotech is seeking an Operations Process Trainer (2nd shift) as part of the Technical… more
- Merck & Co. (Durham, NC)
- …tools and testing equipment)- Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, ... striving for continuous improvement. We work in the local plant linked to our global manufacturing network to ensure the highest quality of raw materials,… more
- Catalent (Philadelphia, PA)
- …of the Clinical development supply division. This individual will have responsibility for Quality aspects related to Quality Systems , Finished Product Batch ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality … more
- Insmed Incorporated (Bridgewater, NJ)
- …total synthesis, physical organic chemistryWorking knowledge of quality systems , validation principles, engineering design, and statistical process control ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...and Best Workplaces for Millennials™ lists.OverviewAssociate Director, Tech Ops ( Process Chemistry) will have responsibility for the management of… more
