- 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)
- …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
- 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 ... Team Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and… 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)
- …and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process ... Mammalian Cell Culture, Manufacturing Scale-Up, Mentorship, Process Characterization, Process Control , Process Design, Process Optimization, Regulatory Submissions, Risk… 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 ... Auditing, Interpersonal Relationships, Management Process, Manufacturing Processes, Manufacturing Quality Control , Process Improvements, Quality Assurance (QA), Quality Assurance Systems,… 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)
- …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
- 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
- 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)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply ... Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply:… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and application level. Some responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports ... A minimum of 6 years of progressively responsible relevant experience Ability to lead a project in the development and implementation of processes and technology… 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
- 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 ... cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure… 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...Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Innate intellectual curiosity,… more
- Merck & Co. (Rahway, NJ)
- …desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings ... management skills.Job-Specific Competencies & SkillsDemonstrated ability to understand, manage and lead in a multi-cultural atmosphere, with an employee base that is… more
- Cytiva (Pensacola, FL)
- …cGMPs, CFR requirements, and quality management practices, including operational controls , CAPA, complaints, audits, and risk management.Analytical and ... to the Quality Director Filtration - Membrane Sites and leads both the Quality Control and Quality Assurance teams located in Pensacola, Florida. This is an on-site… more
