- 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)
- …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. (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
- 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)
- …on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and ... needs of manufacturing are considered as part of the design.- Provide information and drive early alignment and readiness reviews with manufacturing partners to… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... to: - - Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and… 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)
- …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. (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. (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
- Merck & Co. (Rahway, NJ)
- …Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise preparation of multiple product launches in Immunology. You will ... leadership capabilities. Key Responsibilities include: Strategic LeadershipLaunch Strategy Development: Lead the creation of holistic, integrated launch plans that… 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. (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
- 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
- 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)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in support of company objectives, operating model decision, mitigate decision risk , drive action plan development and ultimately improve commercial and clinical ... planning Design, execute and lead all capability benchmarking projects in support of ET and MPS priorities Ensure self and team effectively analyzes and triangulates… 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 ... in the evaluation of potential process changes for effectiveness, value, risk , and priority.Drive the implementation of MES enhancements that would provide… 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
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