- Insmed Incorporated (NJ)
- …(CSV) program. This role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The ... Legal, Compliance , Clinical Operations, Quality and R&D to proactively manage risk across Insmed's technology landscape and protect sensitive patient and… 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. ... External Quality and other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard.Support development and… more
- Merck & Co. (Rahway, NJ)
- …stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate ... Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology )Reporting into the Director Packaging Distribution, Components and Systems… more
- Merck & Co. (Rahway, NJ)
- …stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate ... science is applied to deliverables for new product introductions and technology transfers across the network.Drive proactive risk management activities,… more
- Capital One (Goochland County, VA)
- …projects for one of our lines of business . You will work with the business, technology and risk partners to achieve time sensitive goals and objectives in a ... cyber strategy integration and execution, identification and management of risk for top business initiatives and technology ...RAM, FAIR, PCI DSS) 2+ years experience with information technology audit or compliance management 2+ years… more
- Formation Bio (New York, NY)
- …vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and ... review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, and… more
- Merck & Co. (Rahway, NJ)
- …pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Syner-G BioPharma Group (Boston, MA)
- …and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and ... industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... development teams within and external to Device Development & Technology . The incumbent must be able to work well with all levels of employees and be able to… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical ... all activities are conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional and local site… more
- Merck & Co. (Rahway, NJ)
- …scientific applications and lead squads to build user-friendly scientific data and technology products; handle risk assessment and vendor engagement as needed.- ... together product management, engineering, and data science expertise. We enable data, technology and services that accelerate our scientists' ability to discover and… more
- Capital One (Goochland County, VA)
- …knowledge of payments network operations and ecosystem related risks, as well as risk management and regulatory expectations for a large financial institution. ... of moderate complexity with more than one component, including finance, IT, compliance , credit, security. Provide risk management advice and counsel to… 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 ... internal stakeholders, including supply chain, packaging commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology , to… 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. (Ames, IA)
- … compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.Ability to travel globally approximately 20-30% of the ... and be decisive in an ambiguous environment.Experience and ability to achieve compliance goals through a risk -based approach with a deep understanding… more
- Formation Bio (New York, NY)
- …to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support ... patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug… more
- RGP (San Francisco, CA)
- …our clients. The ideal candidate brings deep expertise across internal audit, enterprise risk , regulatory compliance , technology and cybersecurity paired ... Cybersecurity, and Operational Risk ; Regulatory and Policy Compliance ; Risk and Technology Enablement (data analytics, automation, AI). + Business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of… more
- Formation Bio (New York, NY)
- …all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and ... patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug… more
- Cipla (Central Islip, NY)
- …relationships, negotiating favorable contracts, identifying cost-saving opportunities, and maintaining compliance with regulatory and company policies. Success ... performance and resolve any issues or disputes that may arise. Ensure compliance with regulatory requirements, industry standards, and company policies. Ensure… more
