- Merck & Co. (Rahway, NJ)
- …responsible for device design control activities in the following aspects: Lead and contribute device development design controls for the assigned projects.- ... Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member...and apply regulatory / compliance requirements relative to design controls and risk management activities. Contribute to… more
- Merck & Co. (North Wales, PA)
- …CMC development plans.--Under the guidance of the CIPM Staff Manager & Portfolio Lead , the core responsibility of this senior Project Manager (PM) role will be ... and improving the standards of the PM organization.--Participate in or lead continuous improvement projects that require extensive product development experience and… more
- Eisai, Inc (Nutley, NJ)
- …and ensure JSOX compliance for all processes; ensure standard operating procedures and risk control matrices for all processes related to the treasury function ... to hear from you. The Manager of Treasury and Risk Management monitors and updates various cash flows and...risks related to currency, interest rates, and other factors; lead communication within Eisai to ensure adherence to Treasury… more
- Merck & Co. (Durham, NC)
- …industry technical business processes including:- technical documentation, change control , portfolio management, risk mitigation, deviation management, ... cross-site issues, identify trends and participate in proactively implementing risk mitigation actions.Collaborate with functional teams to contribute to strategic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development ... as an engineering resource for biologics operations, build strong equipment knowledge, lead projects, and provide guidance and training to operationalize the GMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.Perform analysis on quality indicating data and… more
- Merck & Co. (Durham, NC)
- …industry technical business processes such as:- technical documentntation, change control , portfolio management, risk mitigation, deviation management, technical ... issues, help identify trends, and participate in the implementation of risk mitigation actions.Collaborate with functional teams to contribute to strategic… more
- Merck & Co. (Rahway, NJ)
- …equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.Demonstrated ... and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key… more
- Merck & Co. (Rahway, NJ)
- …equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.Demonstrated ... cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for executing… more
- Merck & Co. (Rahway, NJ)
- …Expertise: Utilize extensive experience in design controls , device transfer, control strategies device risk management, and design verification testing to ... syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to...syringes, and complex drug delivery systems.Proven expertise in design controls , risk analysis, control strategies,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and innovate signal ... best practices, foster a culture of continuous improvement in benefit- risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities:Utilize extensive experience in design controls , device transfer, control strategies, device risk management, and design verification ... expert on the device components and combination products and lead a cross functional team members to support global...in managing external partners and suppliers.Proven expertise in design controls , risk analysis, control strategies,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality ... to implement `quality by design` within clinical development programs, using a risk -based approach.The incumbent will be accountable for the overall strategy for… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... on the analysis of inputs, outcomes, risks, and company-wide prioritization.Essential Responsibilities: Lead , mentor, and develop a team of technical staff, fostering… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …not limited to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management/change control and quality systems.Experience with FMEA and risk assessment ... are executed in an effective, efficient, and compliant manner.Participate in Risk Assessments, FMEAs, and system/data process mapping activities.Execute, own, assess… more
- Merck & Co. (North Wales, PA)
- …processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and device technical ... strategic acumen, and execution, along with leadership skills to lead complex cross functional projects.Essential Duties and Responsibilities:The engineer will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.The Compliance Auditor will conduct internal ... audits, support regulatory inspections, and lead investigations to ensure process integrity and GMP compliance. Additionally, the role includes overseeing and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities at the ... coordination and collaboration across relevant cross functional groups.Key Responsibilities Lead projects for the implementation of site strategic initiatives and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process ... programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and… more
- Merck & Co. (Rahway, NJ)
- …and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
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