- 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...preferably in quality assurance, manufacturing compliance, clinical quality , or cell therapy.GxP Quality System… 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...with other pharmaceutical companies).Ensuring that essential elements of the quality management system are in place for… 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
- 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 ... (Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections… more
- Repligen (Waltham, MA)
- …create and revise procedures, practices, and specifications; provide training on quality system and procedures.Maintain strong cross-functional quality ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years… more
- Eisai, Inc (Nutley, NJ)
- …strategy including audit and inspection management, issue management and oversight of the Quality management system . This role is responsible for Good Clinical ... and inspection management, issue management, and oversight of the quality management system ).Conduct complex audits of sites,...as a part of that plan.Champion CQA's mission of ' Quality as enabler of business'; lead global… 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 ... modeling to build analytics solution with best practicesThink as a business system owner for driving-analytics solutions using enterprise BI tools to answer critical… 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
- 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)
- …various Technical Operations groups [e.g., Operations, MS&T, Supply Chain, etc.] and Quality functions to lead all planning and detailed scheduling activities ... efficient scheduling of equipment PMs & Cals while supporting manufacturing plan. Lead material allocation improvements and other optimization projects.An ability to… 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)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based in Raritan, NJ. Role ... OverviewThe Director of Manufacturing Execution System (MES) will be part of Manufacturing Science and Technology (MSAT) Leadership Team and will be responsible for… 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
- 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
- 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 ... teams, Clinical Development teams, Regulatory Affairs, and external partners.ResponsibilitiesEDC System Design & Development: Lead the setup, development, and… more
