- Eisai, Inc (Nutley, NJ)
- …on compliance trends, regulatory changes, and program enhancements C ontribute to compliance RAMP ( Risk Assessment and Mitigation Plan) projects and ... Risk Management, Mentoring/ People Development, Stakeholder Management (Legal/ Compliance )Eisai Salary Transparency Language:The base salary range for the… more
- SMBC (New York, NY)
- …+ Compliance Training + Issues Management + Monitoring & Testing + Compliance Risk Assessment + Communications and Transaction Surveillance + Employee ... stakeholders to support the implementation of enhancements to the Firm's overall compliance program + Assess applicability, coordinate impact assessment and… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment , risk ... and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise wide… more
- Merck & Co. (Rahway, NJ)
- …and responses (IND and BLA) and interacting with Health Authorities. In-vitro immunogenicity assessment , with focus on risk assessment for biologics and ... leader with expertise in biological characterization and structure function assessment of biologic modalities (eg mAb, antibody-drug conjugates, fusion proteins,… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment , risk ... and detect critical flaws including ability to determine areas of potential risk , generate gap analysis and mitigation strategies In-depth knowledge of global… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment , risk ... detect critical flaws including ability to determine areas of potential risk , generate gap analysis and mitigation strategiesIn-depth knowledge of global regulatory… more
- Merck & Co. (Rahway, NJ)
- …blisters) meet safety, efficacy, quality, and robust supply standards. Drive proactive risk management activities, including risk assessment , risk ... and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results. Drive proactive risk management activities, including risk assessment , risk ... and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and ... Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Process Scale Up, Product Formulation, Protein Purifications, Quality Risk Assessment , Reaction Engineering, Risk Assessments, ... ingredients (API) process characterization work by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This… more
- Merck & Co. (Rahway, NJ)
- …packaging process and equipment issues, optimizing processes, and ensuring compliance . Effective collaboration with site-based and above-site based functional teams ... advanced skills in creating and improving business, technical, and compliance processes, and leading high-impact cross-functional teams.Responsible to lead or… more
- Merck & Co. (Rahway, NJ)
- …Device and Combination Product regulations - Demonstrated understanding of the use of Risk Assessment tools - Demonstrated ability to work both independently and ... supporting these program deliverables are executed with technical rigor and drive risk understanding and reduction prior to product launch. The packaging development… more
- Merck & Co. (Rahway, NJ)
- …The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.Primary Responsibilities: ... and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance and operational excellence in the laboratories, and for maintaining a state… more
- Merck & Co. (Rahway, NJ)
- …and documentation of all stages of cell culture process commercialization. Risk assessment , control strategies, process comparability reports, Process ... -Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Experience… more
- Merck & Co. (Rahway, NJ)
- …Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment , Innovative Thinking, Interpersonal Relationships, Mammalian Cell ... the functional area; guide career development; build strong, collaborative teams.Champion compliance and safety while promoting a culture of diversity, equity, and… more
- Merck & Co. (Rahway, NJ)
- …Management (FRM), Global Mindset, Investments Analysis, Management Process, Operational Assessment , Operation Risk Management, Oral Communications, Planning ... limited to, forecasting, reporting, and analyzing operating results; operational risk management and process improvement consulting; managing capital structure,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with change management/change control and quality systems.Experience with FMEA and risk assessment tools.Experience with user requirement documentation and ... understand and assess resource utilization, equipment utilization, change impact, etc.Support assessment of facility fitness, and design of facility upgrades to… more
- SMBC (Jersey City, NJ)
- …and leading the activities related to Risk and Control Self- Assessment , Incident Management and related reporting for Compliance Control Management. ... process mapping and process reengineering + Expert knowledge of risk assessment , issue management and incident management...industry + 7+ years of experience in an Operational Risk or Compliance Risk role… more
- SMBC (Jersey City, NJ)
- …annual budget process to identify expenses for the year in consideration of key risk areas, new initiatives, and overall Compliance strategy. + Provide support ... SMBC is seeking a Vice President to join the Compliance Governance team of SMBC Americas Division. This role...for headcount tracking. + Support the annual Staffing Needs Assessment exercise to evaluate current resources, including assisting with… more
- embecta (Parsippany, NJ)
- …Strategy** + Lead the development and execution of the annual enterprise-wide risk assessment to inform internal audit priorities and departmental initiatives. ... company's operations, with a focus on financial integrity, operational efficiency, regulatory compliance , and enterprise risk management. As a senior leader in… more
