- 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...within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate cLEAN® tools… 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. (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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Responsibilities- GLOBAL CHANNEL STRATEGY CREATION (LINKEDIN PRIORITY)- Lead the development and execution of a unified LinkedIn strategy that ... engagement.- Oversee social media agency supporting LinkedIn globalization efforts- Lead internal review process/submission for establishing global channel and… 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
- 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. (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 ... extensive experience in design controls, device transfer, control strategies device risk management, and design verification testing to develop value-added solutions… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as UK and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and ... of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process… 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
- Aequor (Thousand Oaks, CA)
- …This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital ... team at ATO B20. The NPI Lead is expected to have ownership over the Technology...NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to… more
- Formation Bio (New York, NY)
- …ensuring cost-effective and value-driven vendor partnerships. This individual will lead vendor negotiations, implement procurement best practices, and collaborate ... optimize vendor spend, enhance operational efficiency, and mitigate risks. Lead high-value negotiations with vendors across multiple categories, including software,… 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)
- …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
- 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)
- 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
- 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
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