- Novo Nordisk Inc. (Boulder, CO)
- …our patients Work effectively across all departments, such as Quality Assurance / Control, Chemical Development , Program Management , Regulatory, ... laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality ,...process development , the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Degree with minimum of 10 year' experience in pharmaceutical or biotechnology development functions or clinical quality assurance required Experience ... Director, Development SOP Management Join a Legacy...Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company… more
- Tris Pharma (Monmouth Junction, NJ)
- … Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ... biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet... principles in the design (and resolution) of key quality management system elements to ensure complianceTracks… more
- Merck & Co. (Rahway, NJ)
- … processes at application and infrastructure level (eg, Logical Access, Change Management , System Development Lifecycle, Information Security, IT Ops etc.)Basic ... medical innovation and improve lives.Our Company Corporate Audit and Assurance Services' (MCAAS) mission is to create confidence in...be versed in SOX controls and in the System Development Life Cycle (SDLC) and to be able to… more
- Merck & Co. (Rahway, NJ)
- …risk management , and special project opportunities.Corporate Audit and Assurance Services (MCAAS) Finance Leadership Development Program (FLDP) participants ... Job DescriptionPosition Description: MCAAS Finance Leadership Development Program Finance at our Company is committed...provided with an entry point through Corporate Audit and Assurance Services (MCAAS) to develop a breadth of experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the Quality team… more
- Merck & Co. (Rahway, NJ)
- …will play a pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including ... clear performance goals and metrics for the team to drive excellence.Device Quality OversightOversee the quality assurance of complex devices,… more
- Merck & Co. (Upper Gwynedd, PA)
- …clarity and business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the ... activities within the assigned therapeutic area. This includes operational quality management and inspection management ...development programs, clinical trial processes as well as quality management systems and quality … more
- Merck & Co. (Rahway, NJ)
- …in achieving those objectives. -Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM activities in the ... Demonstrated experience in leading cross-functional teams. Ideally, experience in Clinical Quality Management including Quality Control Activities, Process… more
- Merck & Co. (Durham, NC)
- …including latest trends in validation and best practices. Represent Digital & Data Quality management upon request in local site or system specific meetings ... Job DescriptionResponsibilities: Responsible for the quality aspects of good manufacturing practices (GMP) computerized systems and the supporting infrastructure… more
- Aequor (Thousand Oaks, CA)
- …well as internal network functions within Operations including: Supply Chain, Quality , Process Development , Manufacturing, Global Strategic Sourcing and Finance. ... functional, quality , timeline and cost issues appropriately. Utilize project management processes, software and methodologies to ensure projects are delivered on… more
- Eisai, Inc (Nutley, NJ)
- …support professional growth.Risk Management : Develop and manage global risk management processes and standards.Supplier Security: Oversee the development of ... and oncology, with a strong emphasis on research and development . Our history includes the development of...from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio… more
- Merck & Co. (North Wales, PA)
- …to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong ... a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... and updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label Development process which includes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance , Medical Affairs, ... and the business users to define user information needs.Provide informatics project management , SDLC Quality Model expertise, and computer system validation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to ... with expertise in: oncology, biologics or vaccines.Must have proven expertise within Quality Assurance Research to support Global Research QA including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... myeloma.Legend Biotech is seeking a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role OverviewThe QA Shop Floor… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …qualification, packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and ... process.Direct and coach cross functional team staff in areas such as quality , compliance, safety, project planning, process development , technology … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to 20/30 (Snellen) or betterWorks in a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, ... that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance , or cell therapy. A minimum… more
- Merck & Co. (North Wales, PA)
- …the decision. Operate with Integrity and ensure adherence with organization policies, quality assurance and data protection processes.Conduct innovation proof of ... b) Data Mastering, Data Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value Realization with use of these Data… more
