- iconectiv (Bridgewater, NJ)
- …systems, and compliance frameworks + Partner with risk management and compliance teams to ensure regulatory adherence. + **Collaboration & Stakeholder ... Linkedln. **Responsibilities:** We are seeking a highly experienced and strategic Senior Director of IT & Security Operations to lead our enterprise technology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Senior Director of Quality Operations as part of the Quality team based in Raritan, ... NJ.Role OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities...United States and ensure the sites operate in full compliance with established cGMP requirements. This individual will be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. ... as well as with all applicable regulatory requirements.Support GxP regulatory inspections as required.Support the local Compliance and auditing teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment, ... Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent… more
- 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
- Merck & Co. (Rahway, NJ)
- …enterprise working groups, and cross-functional projects.Ensure all innovations meet regulatory compliance , risk management, and enterprise operational ... Management System Development, Microsoft Azure, Platform Engineering, Product Management, Regulatory Compliance , Report Writing, Requirements Management, Stakeholder… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...to all appropriate departments in Formation Bio to assure compliance with applicable regulations. Remains knowledgeable about current regulations… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... 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 environment OR a… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- …within the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management ... implementing risk control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant standards. Ensure alignment with… more
