- Repligen (Waltham, MA)
- …highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role ... Analysis and Trend Reporting: Analyze NCMR data to identify recurring issues, high- risk suppliers, and common failure modes. Generate trend reports and dashboards to… 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. (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...secure pattern, and how your automation affects broader enterprise risk posture.You won't own the tools-but you must deeply… 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
- 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function ... pharmaceutical industry across different disease areas, and the ability to determine risk factors with and for other technical departments (eg, Clinical, Medical,… 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
- 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)
- …such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter ... Process Improvements, Quality Assurance (QA), Quality Assurance Systems, Quality Risk Management, Technical Writing, Test and Evaluation (T&E), Validation… more
- Aequor (East Syracuse, NY)
- …deliverables within given timelines. Ability to problem solve and apply risk -based critical thinking in a technical environment. Demonstrated history of continuous ... deliverables within given timelines. Ability to problem solve and apply risk -based critical thinking in a technical environment. Demonstrated history of continuous… 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. (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
- 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)
- …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
- Formation Bio (New York, NY)
- …requirements. Identify opportunities for cost savings, contract optimizations, and risk mitigation. Implement procurement analytics and reporting tools to provide ... vendors, and other biotech service providers. Knowledge of contract law, risk management, and compliance in vendor agreements. Ability to work cross-functionally… 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 ... Teams, Operational Metrics, Performance Monitoring, Project Management, Research Databases, Risk Management, Status Reporting, Team Management, Technical Problem-Solving-Preferred Skills:Job… more
- Novo Nordisk Inc. (Durham, NC)
- …SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... manage assignments within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate cLEAN® tools when relevant Lead… 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 ... and making informed trade-off decisions. Facilitate contingency planning and risk mitigation strategies to ensure program continuity. Operational Excellence &… more
