- Insmed Incorporated (NJ)
- …We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding that… more
- Repligen (Waltham, MA)
- …ensure "controls by design."Maintain ITGC narratives, process flows, and risk / control matrices.Identify and drive process improvements, automation opportunities, ... an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal...This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with Internal Audit,… more
- Merck & Co. (Rahway, NJ)
- …device product development, such as manufacturing process development and validation, design control , risk management, material and molding, design validation to ... Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our… more
- Merck & Co. (Rahway, NJ)
- …cybersecurity, and lifecycle best practices (commissioning, qualification, change control , obsolescence, periodic reviews)Provide end-to-end operations support for ... automation representative for new products, process changes, and operational improvements; lead cross-functional teams and participate in tier meetings to drive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support to ... digital solutions at the Raritan site to support base business production processing while liaising with other functions including...The major responsibilities will include but are not limited to: Lead project core teams to ensure on time project… more
- Twist BioScience (South San Francisco, CA)
- …and ISO 14971. This position is also responsible for conducting risk assessments, developing, and implementing corrective actions, and providing technical support ... QMS that complies with ISO 13485 and ISO 14971.Conduct risk assessments to identify and assess potential hazards associated...to the R&D team on quality matters, including design control , process validation, and change control .Conduct audits… more
- Repligen (Waltham, MA)
- …seeking a hands-on, strategic Director of IT & OT Infrastructure to lead the design, implementation, and ongoing optimization of our global technology ... infrastructure. This role partners closely with business and IT stakeholders to build an infrastructure roadmap aligned to business strategy, while overseeing… more
- Cipla (Central Islip, NY)
- …Monitor and manage supplier performance and address any issues that arise to minimize risk . Conduct business in an ethical and professional manner to ensure ... cost-effective & timely delivery of the right material aligned to overall business objective Develop and execute procurement strategies and optimize supply chain… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... on the analysis of inputs, outcomes, risks, and company-wide prioritization.Essential Responsibilities: Lead , mentor, and develop a team of technical staff, fostering… more
- Cipla (Fall River, MA)
- …River, MA Work Hours: General Shift: 8:30AM - 5:00PM (may vary based on business needs) Reports To : Manufacturing Manager Salary Range: $62,400 - $75,400 Purpose: ... leads and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …escalation and the CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality ... monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process… more
- Merck & Co. (Rahway, NJ)
- …Services primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityUnder ... both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Cipla (Reid, WI)
- …River, MA Work Hours: General Shift: 8:30AM - 5:00PM (may vary based on business needs) Reports To : Department Head - Manufacturing Salary Range: $72,800 - $93,600 ... management evaluation of performance trends. Owns quality records (change control , CAPA's, deviations) and delivers to established timelines. Autonomously leads… more
- Merck & Co. (Rahway, NJ)
- … Control , Loss Prevention Strategies, Machine Learning, Microsoft Power Business Intelligence (BI) Desktop, Natural Language Processing (NLP), Python (Programming ... Data Analyst to support the R&D efforts related to the Insider Risk /Trade Secret (IR/TS) program through advanced data analysis and strategic collaboration. This… more
- Merck & Co. (NC)
- …objectives Project management Experience involving utility system generation, distribution and control are preferred. Lead in the identification and ... of the utility department Decisions are guided by policies, procedures, and business plan; receives guidance from manager Provides technical guidance to employees,… more
- ValSource, Inc. (Rahway, NJ)
- …and best practices to ensure compliance. Other Responsibilities: The Project Manager will help lead business development efforts in the region as it relates to ... currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting… more
- Novo Nordisk Inc. (Boulder, CO)
- …will manage CMO's to ensure the continuous supply of product and apply risk mitigation strategies, as well as perform formulation studies in a laboratory setting ... as needed. This position will lead a team of Drug Product Managers and manage...improvement initiatives that are essential to meeting patient and business needs Rapidly and accurately communicate issues to Senior… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …authority and escalate as required.Prioritize sourcing activities based on business needs, criticality, and risk .Manage day-to-day operational decisions ... services, equipment and capital expenditures (CapEx), ensuring alignment with business objectives, quality, compliance, and cost optimization. The role will… more
- Merck & Co. (Rahway, NJ)
- …and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include ... and partners in commercialization and manufacturing in aspects of quality control , compliance, and strategic partnering. Primary Responsibilities: Reports to the… 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
