- Formation Bio (New York, NY)
- …extend product registrations. Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and ... with the HA(s). Ability to read, analyze and interpret scientific and technical information and regulatory documents. Ability to present complex issues… more
- Capital One (Petersburg, VA)
- Senior Manager, IFX, AIML, & Regulatory Risk - Enterprise Services Risk The Enterprise Services Risk (ESR) organization is expanding with a focus on attracting ... valued as we work to redefine the financial sector. This role is within ESR's Technology Product Risk division, on the "AIFX" Team. The Senior Manager in this role… more
- Merck & Co. (Rahway, NJ)
- …commercialization, with practical insight into how these operations generate CMC regulatory content Understanding of CMC operations, technology transfer, control ... SAP Master Data Governance (MDG), Stakeholder Relationship Management, Team Leadership, Technical Management, Technical Projects, Technology Transfer,… more
- Insmed Incorporated (NJ)
- …a blend of technical expertise and business acumen to ensure regulatory compliance , system integrity, and alignment with business objectives across multiple ... of the application, supporting internal and external audits to ensure regulatory complianceManage technical ownership, change control, and documentation while… 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
- Merck & Co. (Rahway, NJ)
- …with potential external device designers, developers, and suppliers for selected device technology platforms.Oversee and serve as a technical integrator of all ... Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell ... in the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role… more
- Merck & Co. (Rahway, NJ)
- … technical team.The Associate Director will lead a team of technical experts responsible providing Logistics and Distribution Technology Center of ... stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate… more
- Merck & Co. (Rahway, NJ)
- …cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution Technology Center of ... stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate… more
- Fresenius Medical Care (Georgetown, KY)
- …vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and FMS policy requirements. ... care while maintaining cost-effective clinical operations in accordance with all legal, compliance , and regulatory requirements and programs. Adheres to all… more
- Capital One (Newport News, VA)
- …applicable controls, risk mitigating, scope, rollout plans, etc..) focusing on Technology Risks related to technical implementation, controls, testing, and ... architecture concepts Provide technical assessments of Capital One's Technology Changes and Change Management Processes to identify identify, assess, and… more
- Capital One (Williamsburg, VA)
- …risks Experience in the financial services industry, including familiarity with regulatory practices; governance, risk, and compliance ; information and network ... Principal Associate, Business & Technology Process Management The Enterprise Services Risk organization...lines of business Research novel trends in an ever-changing regulatory environment, as well as internal process changes, to… more
- Eisai, Inc (Baltimore, MD)
- …and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. ... and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads of Submissions… more
- Capital One (Goochland, VA)
- Senior Lead Software Engineer, Full Stack (Enterprise Platforms Technology ) Do you love building and pioneering in the technology space? Do you enjoy solving ... of driving a major transformation within Capital One. Enterprise Platforms Technology (EPTech) comprises many of Capital One's most important enterprise platforms.… more
- Capital One (Petersburg, VA)
- Lead Software Engineer, Full Stack (Enterprise Platforms Technology ) Do you love building and pioneering in the technology space? Do you enjoy solving complex ... of driving a major transformation within Capital One. Enterprise Platforms Technology (EPTech) comprises many of Capital One's most important enterprise platforms.… more
- Syner-G BioPharma Group (Boston, MA)
- …of manufacturing processes for compliance with quality and regulatory requirements.Provide technical support for the product/process lifecycle and ... and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and… more
- Capital One (Wilmington, DE)
- …Full Stack (Bank Tech) Do you love building and pioneering in the technology space? Do you enjoy solving complex business problems in a fast-paced, collaborative, ... your challenge here. We're building common capabilities and cutting-edge, real-time technology solutions that power critical lines of business including our Retail… more
- Formation Bio (New York, NY)
- …manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and review technical documents in ... Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects...collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions:… more
- Merck & Co. (Rahway, NJ)
- …robust operation while maintaining compliance with all current regulatory expectations.-Receives assignments, direction, and technical guidance from ... Automation, Process Optimization, Product Formulation, Project Management, Quality Control Management, Regulatory Compliance , Regulatory Issues, Safety … more
- Merck & Co. (Rahway, NJ)
- …Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance , Regulatory Compliance , ... affairs, to ensure comprehensive biophysical characterization of products.Ensure compliance with regulatory guidelines and industry standards related… more
