- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …satisfactory regulatory compliance level for these organizations for local and global markets. Liaises with regulatory agencies as needed and internally on GMP ... QA issues.Leads Global GMP Compliance team's participation in local,...to meet changing regulatory and business needs.Lead remediation and risk management to assure the organization's Quality Management System… more
- Merck & Co. (Rahway, NJ)
- …select trade compliance functions that are best performed on a global and/or cross-divisional level. Among other centralized trade compliance activities, GTC ... Job DescriptionGlobal Trade Compliance (GTC) is primarily responsible to determine trade...provisions like 9817 prototype provision for US imports;Work with global trade management programs like SAP GTS and One… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight (CTOR&O), will ... during the vendor selection process.Ensures appropriate oversight from a clinical trial risk and compliance standpoint and establishes a comprehensive interface… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations , responsible for representing the GCO-CQM ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Merck & Co. (North Wales, PA)
- … risk compliance experience (preferably in the pharmaceutical industry)- Global compliance risk experience (US and ex-US) (anti-bribery/anti-corruption ... program; partner with ECO Operations to track and communicate corporate compliance goal KPIs; communicate, counsel and train.--Other Global Compliance … more
- Merck & Co. (Rahway, NJ)
- …Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research ... Division by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel… more
- Merck & Co. (North Wales, PA)
- …Training Lead (STL) will work closely with Quality and Continuous Improvement (QCI), Global Clinical Trial Operations (GCTO), and Global Clinical Development ... projects.This role will lead collaboration efforts, support and lead global projects in relation to:QUALITY & COMPLIANCE ...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Eisai, Inc (Nutley, NJ)
- …other relevant security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue ... stakeholders.Coordinate audit readiness and resolution.Align IT compliance budget with risk appetite and global strategy.Educate end-users on IT … more
- Merck & Co. (Durham, NC)
- …periodic shop floor audits, direct in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including accessing ... work with constituent groups include but not limited to internal customers ( operations , technology and labs)Applies understanding and is able to anticipate the needs… more
- Merck & Co. (Durham, NC)
- …and warehouse.--As the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global ... Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility. Members of the … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Small Scale Organics (SSO) Operations Specialist The Small Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing ... development, and seamless technology transfer to commercial sites. The SSO Operations Specialist will provide hands on assistance for daily production activities… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people.This role as a Manager, Operations will be an energetic, leader with strong interpersonal, leadership, and ... based on business unit needs during start up and operations , and specific assignments.This position is for days reporting...- that impact the efficiency and effectiveness of own unit; Compliance - Responsible for creating and sustaining a culture… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description The Associate Director, Technical Operations within Global Clinical Supply (GCS) is responsible for managing all aspects of ... infrastructure-related projects to establish, upgrade, and modernize Clinical Supply Operations (CSO) facilities.-Specifically, this role will: Monitor utilization of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionP2 - Pilot-Scale Operations Lab ManagerJob Summary: We are currently seeking a highly motivated candidate to join our team as a Pilot-Scale ... Operations Lab Manager. This role involves managing, organizing, and...lead times.Oversee shipping activities for equipment and samples, ensuring compliance with all relevant regulations and guidelines.Calibrate, conduct quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the evaluation of potential process changes for effectiveness, value, and risk . Work cross-functionally across Technical Operations and interface with ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...seeking a Manufacturing Engineer as part of the Technical Operations team based in Raritan, NJ. Role Overview The… more
- Merck & Co. (Rahway, NJ)
- …provide guidance from a medical perspective on strategy and tactics that ensure compliance and alignment with standards of care.- The Veterinary Insights and Medical ... product concepts and solutions considering competitive factors, market demand, risk management, program economics, strategic fit, and operational complexity.Identify… more
- Merck & Co. (Rahway, NJ)
- …and Global Workplace & Enterprise Services (GWES) to ensure compliance with regulatory requirements, corporate standards, policies and procedures related to ... supports research laboratories, clinical manufacturing, facility management and office areas for global teams as part of the Corporate Headquarters.- The Rahway EHS… more
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