- Merck & Co. (Austin, TX)
- …enabling automation pipelines that support AI-driven defense and enterprise-scale risk reduction.Job Description:You'll be working in a forward-leaning engineering ... will be foundational to how we scale AI, automate risk response, and reduce manual toil across the enterprise.As...for protected veterans and individuals with disabilities.- For more information about personal rights under the US Equal Opportunity… more
- Merck & Co. (Rahway, NJ)
- …documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance ... and inspire accountabilityEthical, resilient, and committed to excellenceSkilled in risk management, team facilitation, and strategic planningExperience in commercial… more
- Repligen (Waltham, MA)
- …highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role ... logging of issue details, affected part numbers, quantities, and supplier information .Data Analysis and Trend Reporting: Analyze NCMR data to identify recurring… more
- Merck & Co. (Rahway, NJ)
- …experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well ... manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence clinical and… more
- Merck & Co. (Rahway, NJ)
- …regulatory inspections. Independently performs audits of batch documentation, data, information , procedures, equipment and systems, and/or facilities to ensure the ... such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of GxP audits assigned in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned with the company's strategy and ... trending and signal detection is communicated to stakeholders for risk mitigation.Support the stakeholders in identifying and defining quality improvement… more
- Merck & Co. (Rahway, NJ)
- …for how automation interacts with ITSM, detection engines, identity systems, and risk scoring frameworks.Serve as lead integrator between the Automation & AI team ... environment.Preferred QualificationsFamiliarity with ITSM workflows, CMDB, detection logic, and risk -based prioritization.Experience leading technical projects with high-impact outcomes across… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also ... drawingsProcess development and technology transfer experience including the use of risk assessment and process capability (Ppk) tools.Candidate should have solid… more
- Merck & Co. (Rahway, NJ)
- …and track KPIs for performance, member experience, and operational efficiency. Risk & ComplianceMaintain strong controls and procedures to comply with ... Reg Z, PCI DSS, and FFIEC guidelines.Champion the credit union's enterprise risk management strategy of "Slow Down, Stop, Escalate"Team LeadershipLead and develop… more
- Merck & Co. (Rahway, NJ)
- …apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations for ... experienceHas broad knowledge of medical device development, design controls and risk managementLed and managed development of DHF (design history file) deliverables… more
- Merck & Co. (Durham, NC)
- …Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, ... provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer,… more
- Insmed Incorporated (San Diego, CA)
- …guidelines.ResponsibilitiesResponsibilities (Essential Role Responsibilities):Establish and maintain a risk -based and scientific-based quality system to support ... they are accurately represented in current SOPs is essential.Broad knowledge of risk -based quality systems approaches consistent with ICH E6 for Good Clinical… more
- Merck & Co. (Rahway, NJ)
- …compliance/quality readiness of these suppliers at all times through the implementation of risk assessments and frequent walkthroughs.- The number of EPs an Ops AD ... Agreements, as requiredFacilitates the collection of contract manufacturer's capacity information (eg stated capacity, firm capacity, future capacity plans, time… more
- Merck & Co. (Rahway, NJ)
- …candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This ... following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).-… more
- Merck & Co. (Rahway, NJ)
- …(MCAAS) primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityThe ... of the audits and assessments.Demonstrates knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex… more
- Merck & Co. (San Francisco, CA)
- …ensure successful implementation of project plans.- Escalates issues through the risk log and drives problem-solving and resolution within the team.Operating Model ... requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the US Equal Opportunity Employment laws,… more
- Formation Bio (New York, NY)
- …solutions to common program challenges, including resource constraints and risk mitigation strategies. Develop contingency plans for critical program elements ... to clarify priorities, and recommending decisions based on available information . Planning & Prioritization Develop and maintain comprehensive program roadmaps,… more
- Novo Nordisk Inc. (Durham, NC)
- …roadmaps and participating/conducting Proof of Concept Present and define initiatives & information accurately & explain industry jargon in a clear manner for ... SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enterprise technologies and will also be responsible for performing technical risk and vulnerability assessments at the network, system, and application level. ... responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports directly to the manager of Global… more
- Merck & Co. (Rahway, NJ)
- …Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will include:Project support ... Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users. Conduct… more
