- Dexian - DISYS (Summit, NJ)
- …automation solutions to make the development process better and faster.Takes a lead role in driving the usage of latest technology/Frameworks.Motivates the team to ... use the tools that improve the quality of the product. Job Duties:Configuration/threshold parameters for all...Client and FSDM.Conduct data assessment requirements to evaluate data quality and adequacy to run the models.Assist production and… more
- Careers Integrated Resources Inc (Summit, NJ)
- …successful incumbent must interface closely with different functional organizations, including Quality Assurance teams. Working conditions (us only): . The incumbent ... (Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools. . Lead investigations and cross functional investigation teams, and close reports… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in ... Raritan, NJ. Role OverviewThe Quality Compliance- Lead Auditor CAR-T is responsible for regulatory compliance supporting...the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …External Alliance Committee. b. Quality leadership team c. Develop/ chair or co- lead quality council as necessary.Ensure the vision is in place to build ... readily available for presenting at senior leadership meetings.Ensure and lead the establishment of the Quality Systems for the Research Quality area, and… more
- Merck & Co. (Rahway, NJ)
- …the development, optimization, and validation lifecycle activities of analytical methods.Support Quality by Design (QbD) activities and lead discussions on ... join our Large Molecule Analytical Validation team to serve as an Analytical Program- Lead . The lead must take charge in overseeing and guiding analytical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... innovative, science-driven portfolios with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to drive strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead ...with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. ... portfolio. This role as CSO (Clinical Supply Planning and Operations) Project Lead is primarily responsible for developing and updating Study Supply Plans, managing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... GRACS, including training process standards and strategies to ensure optimal quality and compliance in GRACS business processes.Core Responsibilities may include and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Job Summary: The Vice President, Global Team Lead is a senior, cross-functional leader in Daiichi Sankyo's global R&D organization. ... reports to the Head of Asset and Portfolio Management. The VP - Global Team Lead is a member of the Asset and Portfolio Management Leadership Team whose vision is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before ... Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy: Clinical study leader (CSL) or major scientific/medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before ... Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major scientific/medical… more
- Rose International (New York, NY)
- …the department''s Manager Control Assessment (MCA/RCSA) with regard to completeness and quality Lead MCA annual and quarterly review and challenge sessions ... Risk and Control Committee (BRCC) Development of MCA Risk and Control framework Lead components of the MCA transformation work as required by the Global Consent… more
- Merck & Co. (Rahway, NJ)
- …another's thinking and approach problems collectively. As an ERP Direct Procurement Lead , you will: Design and shape our Company's Direct Procurement solution ... our Company's regulatory commitments, sustainability requirements and highest standards of quality . Coordinate and work closely with other work streams and… more
- Merck & Co. (Rahway, NJ)
- …state business objectives. Within the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all areas of SAP Technology.-They ... Middleware/Integration and Reporting/Analytics standards, patterns, and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs ... direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for… more
- Merck & Co. (Rahway, NJ)
- …knowledge of pharma CSV and SDLC processesPreferred knowledge of quality and manufacturing content management processes OpenText Documentum experience, particularly ... to work independently and as per the directions from the Lead Business AnalystHighly organized with strong time-management skillsKnowledge of system development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking Manufacturing Execution Systems Lead as part of the Manufacturing Excellence team based in Raritan, New ... Jersey. Role OverviewThe Manufacturing Execution Systems Lead will be part of Manufacturing Excellence and will be responsible for overseeing the manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead ... tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Drive continuous improvement.Have advanced computer skills… more
