- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OOS monitoring and trending program)Contribute to developing and/or improvements to quality systems in support of global implementation of changes ... initiatives.Experience in developing, writing and approving technical documents.Experience with Quality systems (Change control, investigations, LIMs, etc.).Extensive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …potential suppliers, manage RFI/RFP and term sheet development, and negotiate contracts. Lead cross-functional teams and collaborate with Quality , Legal, CMC, ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory, Quality , Legal, Privacy and Finance. External relationships include Customer Care… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... Health Canada. This individual also supports senior staff with required systems and process maintenance. Responsible for supporting the preparation, delivery,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA and ICH regulations and guidelines Expertise in safety databases, call center telephony systems and quality systems Knowledge of NNI supported disease ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....relation to department objectives. Essential Functions Leadership & Oversight Lead and manage the global Case Processing team, fostering… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including FDA and ICH regulations and guideline Expertise in safety databases and quality systems Knowledge of NNI supported disease states preferred (eg, ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Review Board as required. Essential Functions Leadership & Oversight Lead and manage the Medical Review Case Processing team,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within budget, per direction, and are internally consistent with group deliverable quality Systems and Data Management Responsible for gross-to-net forecast ... customer alignment as necessary. The position is responsible for: Lead support for development of gross-to-net forecasts for Rare...and evolving business needs Continuously reviews and evaluates the quality of data and new data sources used in… more
- Merck & Co. (Rahway, NJ)
- …Business Systems , Change Management, Content Management, Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality ... ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The… more
- Merck & Co. (Rahway, NJ)
- … Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... qualification through ongoing training and continuing education programs.Coordinate with Site Quality leads on audit refusals and postponements. Lead project… more
- Merck & Co. (Rahway, NJ)
- …Experience supporting compliance investigations and change management. Experience working with Quality systems . Experience working in an environment with an ... degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our ... SAP Finance implementations, upgrades and integrations (including S/4HANA), ensuring quality , on-time and on-budget execution.Provide leadership and direction to a… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Formation Bio (New York, NY)
- …them for regulatory inspections. Overseeing the development, implementation, and upkeep of quality systems and procedures, including SOPs, batch records, and ... and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the...requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of… more
- Merck & Co. (Rahway, NJ)
- …Management System (QMS) documents pertaining to USDA requirements for facility design, auditing, quality systems and ensure team and company adherence to these ... Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead .-- The responsibility...Quality Management, Quality Management System Auditing, Quality Management Systems (QMS), Quality … more
- Terumo Medical Corporation (Somerset, NJ)
- …and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and processes. Key responsibilities include planning and ... Sr. Clinical Quality Specialist Date: Oct 21, 2025 Req ID:...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …ensures that the manufacturing building, relevant campus infrastructure, equipment, and systems support business goals and comply with safety, regulatory, and ... response to unexpected issues are critical for this leader.Key Responsibilities Lead and oversee all engineering management including asset/reliability, data … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and site-specific procedures.The position requires in-depth knowledge of ERP systems in a Manufacturing/Supply Chain environment, strong analytical and advanced ... requirements and disruption to supply.Maintain system planning parameters (eg lot size, lead -time and safety stock levels) within the site ERP.Assist with the… more
- Genscript USA Inc. (Piscataway, NJ)
- …matter expert (SME) for mechanical, electrical, and plumbing (MEP) systems —particularly HVAC—during major facility construction and expansion projects (230,000+ sq ... is essential. This role offers a rare opportunity to design foundational systems for how we manage equipment and facilities, while also driving in-house… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Calibrations are scheduled, completed, and properly documented with supporting records attached. Lead the Building and Environment monitoring team to ensure the ... control and update / communicate with all teams with any emergencies and disruptions. Lead the maintenance and metrology support specialists to ensure all vendors for… more
