- Merck & Co. (Rahway, NJ)
- …external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management activities. Lead the preparation ... and customer requirements.- -Principal ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation… more
- Merck & Co. (Rahway, NJ)
- …design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and ... including engineering design, engineering analysis and testing, medical device design controls , risk management, test method/ fixture development, design… 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 & ... Job DescriptionWe are seeking a solution-oriented Platform Engineering Lead to drive automation and orchestration across the cybersecurity technology stack. This is… more
- Merck & Co. (Rahway, NJ)
- …environment.Recognition:-Celebrate team achievements and foster a culture of appreciation.Innovation:- Lead business improvement initiatives and leverage your ... and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process… 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...automation workflows under the direction of the Platform Engineering Lead . You will be expected to go beyond implementation-to… more
- Aequor (Thousand Oaks, CA)
- …and the NPI Lead needs to be able to understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines. ... 100% Onsite supporting ATO Copy of AMAGJP00014054 Standard business hours You've worked hard to become the...Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems,… more
- Merck & Co. (Rahway, NJ)
- …servicing.Establish and track KPIs for performance, member experience, and operational efficiency. Risk & ComplianceMaintain strong controls and procedures to ... Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments… more
- Novo Nordisk Inc. (Durham, NC)
- … and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical...from the manager. Responsible for providing data-based insights as business and manufacturing intelligence to an end-consumer business… more
- Merck & Co. (Rahway, NJ)
- …activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject ... by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not… more
- Merck & Co. (Durham, NC)
- …and associated standard operating procedure (SOP) updates to align to SAP and business processes. -This position will also be responsible for working directly with ... and input to every department on site across a wide range of business activities.- Reporting directly to the Director, Supply Chain Management, the successful… 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 ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Merck & Co. (Durham, NC)
- …Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with ... goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and application level. Some responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports ... insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance & Operations works closely across… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change Controls , and other product life cycle management activities.Partner with… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... in media/solution development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture predictive modeling (omics (transcriptomics,… more
- Merck & Co. (Rahway, NJ)
- …reports (SORs) to promote fast and efficient closure.As needed, safely perform High Risk Work involving hazardous energy control .Identify and follow through on ... SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relevant skills and techniques in spirit of best-in-class CI leadership Lead development business development analytical due-diligence in alignment with ... by MPS, F&O leadership and in conjunction with current and anticipated business priorities Drives and directs assimilation of market intelligence to ensure that… more
- Merck & Co. (Rahway, NJ)
- …Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems, Electronic Common Technical Document (eCTD), Ethical ... desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... 7 years of relevant experience is required. Demonstrated experience translating business needs to system requirements. Cell/Gene Therapy cGMP manufacturing and… more
- KeyBank (Brooklyn, OH)
- …line(s) of business with the identification, measurement, and management of risk ; development and implementation of sustainable controls ; and development or ... with corporate standards.* Lead or support enterprise risk mitigation projects, business continuity and other...to create, implement, evaluate and enhance processes in internal controls .* Risk & Control Self-Assessment… more
