- 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)
- …experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well ... and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work… more
- Merck & Co. (Rahway, NJ)
- …portfolio.Reporting directly to the Biologics Cell Culture Commercialization Leader, you will lead a team of approximately 3-5 scientists, who lead ... process validation, second generation process development and health authority licensure.-You'll lead the charge in transforming our late-stage pipeline into reality… 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
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… 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 ... regulatory inspections. Independently performs audits of batch documentation, data, information , procedures, equipment and systems, and/or facilities to ensure the… 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...participating/conducting Proof of Concept Present and define initiatives & information accurately & explain industry jargon in a clear… more
- Merck & Co. (Rahway, NJ)
- …and apply regulatory / compliance requirements relative to design controls and risk management activities. Lead the preparation of materials for program ... ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation and/or ensure effective execution of the… more
- Merck & Co. (Durham, NC)
- …Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply: ... Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External… more
- Merck & Co. (Durham, NC)
- …and process enhancements throughout the supply chain - Project Management Lead and sponsor all Supply Chain Logistics initiatives surrounding qualification support ... and business processes related to any new project implementations.Site supply chain lead and coordinator for the successful implementation of SAP S4/HANA targeted… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments ... and track KPIs for performance, member experience, and operational efficiency. Risk & ComplianceMaintain strong controls and procedures to comply with… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other ... regulations and guidelines.ResponsibilitiesResponsibilities (Essential Role Responsibilities):Establish and maintain a risk -based and scientific-based quality system to support GCP.Oversee regulatory… 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 maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and sponsor various department… more
- Merck & Co. (Rahway, NJ)
- …information (eg stated capacity, firm capacity, future capacity plans, time horizon/ lead times required, comments/concerns, etc.), presents the information to ... 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… more
- Merck & Co. (San Francisco, CA)
- …seasoned Project Manager with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on helping the team build ... decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager, will be responsible for… more
- Formation Bio (New York, NY)
- …the organization, adapting style to different audiences and simplifying complex information . Lead productive team meetings, fostering collaboration and ensuring ... solutions to common program challenges, including resource constraints and risk mitigation strategies. Develop contingency plans for critical program elements… more
- Merck & Co. (Upper Gwynedd, PA)
- …including assessment of the probability of regulatory success together with risk mitigation measures.- Lead development and execution of global product ... include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory… 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. (Durham, NC)
- …vaccine manufacturing facility in Durham, North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate ... functions.Demonstrated skills in complying with one or more regulatory programs: RCRA and High- Risk Work (eg elevated work, confined space, hot work, lock out tag… more
- Merck & Co. (North Wales, PA)
- …execution of a clinical trial.May serve as the clinical trial team leadMay lead team in key study planning, development, and execution elements (eg, data management ... reports, study close out activities).Leads team for timeline management, risk identification and mitigation, issue resolution.May facilitate and collaborate with… more
