- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational leader...and systems support business goals and comply with safety, regulatory , and sustainability standards. This position is a key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... initiatives for continuous quality improvement.Deputize for the Sr. Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Merck & Co. (Rahway, NJ)
- …Recruitment, Process Analytical Technology (PAT), Professional Networking, Raw Materials, Regulatory Compliance , Regulatory Submissions, Release Testing, ... entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance ...a state of inspection readiness at all times. The Director should be well engaged with regulatory … more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...life cycle changes, investigations, trouble shooting and continuous improvement initiatives to guarantee the robustness and compliance … more
- Merck & Co. (Rahway, NJ)
- …Master Data Management (MDM), Project Management, Project Scheduling, Project Strategy, Regulatory Compliance , Regulatory Requirements, Resource Stewardship, ... Job DescriptionThe Director , Master Data Management (MDM) will lead a...Ensure master data practices comply with internal policies, external regulatory requirements, and audit expectations. Education & Experience :Bachelor's… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... minimum of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... Evidence (RWE) Capabilities & Analytics team is looking for an Associate Director , Data Strategy & Partnerships with expertise in data strategy, advanced analytics,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This role ... principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF strategy, foster cross-functional collaboration, and… more
- Merck & Co. (Rahway, NJ)
- …and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our ... Job DescriptionDir, Engineering - Director , Assembly and Packaging Platform Technical LeadershipReporting into...internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant… more
- Prysmian (Bridgewater, NJ)
- …production facilities. This role ensures consistent implementation of quality systems, compliance with industry standards, and continuous improvement initiatives ... Mark at Prysmian! (https://www.youtube.com/watch?v=ZVx-NAGfjEs&feature=embtitle) **Position Summary:** Reporting to the Director of Quality, the Regional Quality Manager is responsible… more
- Merck & Co. (Rahway, NJ)
- …in a highly regulated industry with strict standards adherence and compliance initiatives .Demonstrated knowledge of Process Safety including HAZOP and ... and Health, Pharmaceutical Guidelines, Process Safety, Project Human Resource Management, Regulatory Compliance , Safety Audits, Standards Compliance ,… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities include, but are not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of ... management and project teams to help drive pipeline progression and strategic initiatives . Contribute to assessment of capability gap(s) and expand toolbox for… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing, Process Improvements, Product Formulation, Quality Management Systems (QMS), Regulatory Compliance , Regulatory Requirements, Safety Standards, ... from the Operations Director .Works within budgetary/financial objectives set by Director - Compliance - Responsible for creating and sustaining a culture that… more
- Merck & Co. (Rahway, NJ)
- …and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our ... Job DescriptionReporting into the Director Packaging Platform Technical Leadership the Associate ...internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …Reporting to the Chief Commercial Officer, US Innovative Medicines, the Senior Director of Commercial Analytics and Insights will play a pivotal and highly ... maintenance of a centralized, accessible data repository. + Collaborate with IT, compliance , and external vendors to ensure data integrity, privacy, and … more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …application of new technologies and solutions to help achieve goals. + Ensure legal/ regulatory compliance and medical accuracy of marketing materials and conduct ... This new position will report directly to the Executive Director , Marketing and will play a key role in...optimize content across channels. + A/B testing - lead initiatives for creative to improve engagement and relevance. +… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …Supply Chain, Regulatory , Quality, and Finance to align on strategic initiatives . + Support business planning, S&OP meetings, and commercial review forums. + ... in ERP/order systems for greater efficiency and customer satisfaction. + Ensure full compliance with SOPs. Trade Show Management: + Lead planning and execution of… more
- SMBC (New York, NY)
- …to facilitate the consistent cross functional delivery of New Business proposals in compliance with regulatory and group guidance. + Engage business leads and ... the end-to-end delivery of new product and new business activity initiatives . Working closely with stakeholders across multiple business divisions and support… more
