- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …and effectively, and within budget.Regulatory Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to include the ... OverviewAs an integral part of the Lovelace Leadership Team, the Chief Academic Research Officer (CARO) will develop and lead the all of the Institute's Academic … more
- Novo Nordisk Inc. (WA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership… more
- Insmed Incorporated (Bridgewater, NJ)
- … Compliance program and foster accountability for compliancePromote a continuous improvement mindset and propose enhancements to the Compliance Program ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we...maybe you will be our next Manager of US Compliance ! This role will implement day-to-day support across the… more
- Merck & Co. (Durham, NC)
- …in the network of life-saving medicines and vaccines. - The Associate Director, Quality Systems and Compliance provides expertise in the coordination of ... during critical processing and manufacturing. FUNCTIONAL EXPERTISE: The Associate Director, Quality Systems and Compliance will be responsible for comprehensive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and metrics. Support continuous process improvement , interpretation of regulations, quality and compliance with regulations and company standards, policies ... and metrics. Support continuous process improvement , interpretation of regulations, quality and compliance with regulations and company standards, policies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mitigated in collaboration with the business functions. Identify appropriate continuous improvement initiatives for quality and compliance related ... improvement to stakeholders via the QMS scheme (ie, Quality Management Review, Quality Review Board) across...that all functions consistently operate in a state of compliance .Facilitate the implementation of the quality strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Manager, ... Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible...Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups which are established to ensure… more
- Insmed Incorporated (Bridgewater, NJ)
- …Deviation/CAPA/EC and product quality complaint investigations within QMS, ensuring compliance , continuous improvement , and day to day operations. Thorough ... Quality Complaints. The primary responsibilities include managing QA Compliance activities, including technical writing of Deviations/CAPA/EC documents. Monthly/Quarterly… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for established metrics and identifying potential new metricsSupporting continuous improvement projects assigned potentially within regulatory compliance , ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training… more
- Merck & Co. (Durham, NC)
- …a Right First-Time culture by reducing waste and constantly driving continuous improvement -- Review and approve compliance documents, as per procedures or ... ramp-up of the facility.Leads and provides input into continuous improvement opportunities.-Accountability - Operational LeadershipEnsure that Shift(s) objectives are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and issue management with strategic development partners.Close partnership with clinical quality management and other compliance functions within and outside ... clinical trial execution in one or more key functions (eg clinical research & development, clinical science, clinical quality assurance, project management)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …due diligence activities during the vendor selection process.Close partnership with clinical quality management, SVO and other compliance functions within and ... clinical trial execution in one or more key functions (eg clinical research & development, clinical science, clinical quality assurance, project management)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigator grants and pass-through costs.Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Contribute toward the ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis new role ... 1) Lead and implement the establishment and oversight of an Inclusive Research and Patient Voice Strategy and Infrastructure, 2) Identify innovative approaches,… more
- Merck & Co. (Durham, NC)
- …embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The HVAC&R Lead ... Responsible for supporting (Our Manufacturing Division) Divisional site mission by assuring quality of products and services are of the highest quality ,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDescriptionThe Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated ... development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning production,… more
- Merck & Co. (North Wales, PA)
- …Responsible for the coordination and execution of observational or non-interventional research studies (including Post Authorization studies), in compliance with ... Procedures (SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial ... operational processes and implementing changes to enhance efficiency, productivity, and quality . Encouraging a culture of continuous improvement , promoting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Enterprise Functions Insights (eg Finance & Supply Chain, People & Organization, Legal, Compliance , etc.). This person is the focal point for CMR and all Enterprise ... and unified insights across NNI Ensure clear and ongoing communication of research results, key conclusions, and recommendations through formal and informal channels… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process experience in one or more key functional areas (eg clinical research & development, clinical science, clinical quality assurance, project management) ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Associate Director,… more
