- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems … more
- Merck & Co. (Durham, NC)
- …our products. We work in the manufacturing facility with a "Safety First, Quality Always" mindset, always striving for continuous improvement. We work in the local ... plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.The Maurice R. Hilleman… more
- Merck & Co. (Rahway, NJ)
- …a single-use environment, and bioprocessing equipmentStrong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for ... Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality ... for life-changing animal vaccines. Your leadership will shape manufacturing systems and release processes that enable reliable, efficient vaccine production… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …providing quality and compliance input for continuous improvement; and remediations. Lead quality driven continuous improvement projects to reduce turnaround ... procedures.Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.Maintain quality practices in… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.- Position Description - This is a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …potential suppliers, manage RFI/RFP and term sheet development, and negotiate contracts. Lead cross-functional teams and collaborate with Quality , Legal, CMC, ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of ... label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Good Documentation Practices (GDP).Perform tasks on time in a manner consistent with quality systems and cGMP requirements.Work in a team based, cross-functional ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Manufacturing Lead Operator as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Upper Gwynedd, PA)
- …on existing Data & Analytics (D&A) products and link usage to business outcomes. Lead data transformations, data quality , data governance, advanced analytics, and ... SDLCManaging diverse projects and processes within GCTO/MAP Teams.Champion data quality , integrity, and reliability by designing and promoting best practices.Bridge… more
- Merck & Co. (Rahway, NJ)
- …research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections.Profound knowledge and ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head...clinical development programs, clinical trial processes as well as quality management systems and quality … more
- Eisai, Inc (Nutley, NJ)
- …and drive execution as a part of that plan.Champion CQA's mission of ' Quality as enabler of business'; lead global initiatives for continuous improvement.Trend ... If this is your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution of… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on ... represented in current SOPs is essential.Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice.Must… more
- Merck & Co. (Durham, NC)
- …production, and quality groups to ensure facility operations and systems comply with required standards. Lead / participate in discussions with contractors, ... quality without compromising superior customer service. FUNCTIONAL EXPERTISE: Lead in the identification and implementation of process improvement projects,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and ... Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical… more
- Insmed Incorporated (San Diego, CA)
- …This role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency ... Lead the setup, development, and validation of EDC systems , including configuration settings, integration with other applications, and...GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance:Ensure EDC systems comply with… more
- Merck & Co. (Rahway, NJ)
- …Engineering, Inventory Control System, Inventory Management, Mechanical Testing, Medical Device Quality Systems , Negotiation, Project Management, Quality ... Responsibilities: Strategic LeadershipDevelop and implement digital strategies to ensure high- quality , compliant, and actionable data flows across DD&T and supply… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures for the signaling activities to ... continuous improvement around development of new signal workflow/process, development of quality systems and tools, updates to templates and procedural… more
