- 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. (Rahway, NJ)
- Job DescriptionRole Summary:The USMA Health Systems (HS) Director, Strategic Medical Implementation Lead , plays a critical leadership role in advancing the ... major initiatives with robust 30/60/90-day milestone tracking.Performance Measurement & Analytics Lead Health Systems value creation by identifying areas of… more
- Merck & Co. (Rahway, NJ)
- …worldwide regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area ... deviation and/or out-of-specification approval, change management approval, etc.Support the Quality Program Lead on inter-departmental and cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Merck & Co. (Rahway, NJ)
- …(eg, cGMP) supporting biopharmaceutical or enzyme manufacturing processes.Knowledge of quality systems , regulatory requirements, and documentation practices in ... Microbial Process Operations (MPO) Team is seeking a Senior Specialist to lead operations supporting enzyme process development and characterization. Our team is… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems .Excellent organizational skills.Desire and willingness to learn, ... its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the… more
- Merck & Co. (Rahway, NJ)
- …of 6 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area. Strong knowledge ... Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member of our team, responsible for spearheading design control efforts… more
- Merck & Co. (Rahway, NJ)
- …role involves leveraging your expertise in packaging, particularly in thermal protection systems and in distribution testing. We value the application of sound ... with experienced supervisors who provide valuable guidance while you lead projects from conception to implementation. Primary responsibilitiesLead the development… more
- Merck & Co. (Rahway, NJ)
- …Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability ... and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director).-This role… more
- Merck & Co. (Rahway, NJ)
- …solutions to business needs by designing and implementing new data management systems Employ innovation and technology solutions to manage data warehousing more ... and Strategic Roadmap, supporting the organization's transition toward future-ready systems and modern data architectures. Primary Activities Design and develop… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality , and innovation of the credit union's payments ... from a payments perspective.RequirementsBachelor's degree in business, Finance, Information Systems , or related field; MBA or other advanced degree preferred.8… more
- Merck & Co. (Rahway, NJ)
- …results, remove barriers on portfolio or scientific prioritiesEvaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging ... offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be… more
- Merck & Co. (Rahway, NJ)
- …on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and ... and Women's Health programs. Prioritizes and oversees execution of high quality and timely health authority engagement in attaining desired results. Reviews… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborating with study teams, CROs, external vendors, and partners to ensure high quality deliverables are on time to support drug development processes and global ... study level.- Proactively identifies and manages risks to data quality and/or timelines at the study level and escalates...study level and escalates issues to the DM program lead .- Will manage DM resources of assigned studies; provides… more
- Formation Bio (New York, NY)
- …for a builder who thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that transform both structured and ... infrastructure at the intersection of data engineering and applied AI. You'll lead efforts to ingest and transform unstructured and structured research, biomedical… more
- Merck & Co. (Rahway, NJ)
- …control environment at our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management supervision in addition ... papers (including walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of… more
- Merck & Co. (New York, NY)
- …health care providers such as physicians, nurses, pharmacists as well as quality directors, immunization managers, and office managers. Within their geography there ... in order to execute their role including:- clinics, health departments, integrated delivery systems , and hospitals.- The VCR is a key member of the local Customer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThis role is key leadership position within Global QMS and Global Quality Assurance. Overall accountability is develop strategic framework work for GxP ... across DS group including business units, functional units and corporate functions. Lead Training function team and Document and record management function team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Eisai, Inc (Nutley, NJ)
- …close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical study timelines. Gathers ... internal reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing documentation under the… more
