- Tris Pharma (Monmouth Junction, NJ)
- …immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations provides expert ... of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance. Collaborating closely… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality ... that delivers reliable, high- quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Millsboro, DE)
- …state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions ... DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/… more
- Catalent (Harman, WV)
- …biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/ Quality Control function with a strong familiarity ... Position Summary The Director , Quality Systems is responsible for...supervisionAbility to work in fast paced environment supporting the quality assurance/ quality control departments of… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality ... years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug… more
- Creative Financial Staffing (Columbus, OH)
- …and reporting systems ensuring compliance with appropriate GAAP standards and regulatory requirements. Maintains internal financial control and auditing ... in place to support effective program implementation and ensure the quality of financial reporting both internally and externally. Position Responsibilities:… more
- Merck & Co. (Rahway, NJ)
- …seamless access to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, completeness, and ... disease-specific databases (eg, Cancer Genome Atlas).Stay informed about the availability, quality , and limitations of various data sources and their relevance to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Director of Quality Operations provides direct support for all Manufacturing and Quality activities. This position supports the ... Investigations, Change Control , and CAPA(s)Work with Area Management to drive Quality Culture Providing Quality Assurance oversight in the Sterile production… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business strategy within one or more ... R&D QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission… more
- Merck & Co. (Rahway, NJ)
- …and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic ... practices.SAP Development DEV/OPSLead the SAP development team in delivering high- quality and efficient solutions.Define and enforce coding standards, development… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Engineering Director is directly responsible for leading the Engineering team in the successful design, construction, and commissioning of ... strategies and policies and represent the company with customers and regulatory agencies.Directly responsible for the management of external professional Engineering… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational ... users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver… more
- Aequor (Seattle, WA)
- …great communication - Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports ... expressing Quality principles Position Reports to Jenna Walker - Associate Director , QA Training & Document Control Education: Bachelor's degree or… more
- Merck & Co. (North Wales, PA)
- … Quality Control including solid knowledge of global GMP Quality and regulatory requirements.Required Experience and Skills:Strong understanding of cGMPs, ... Quality Management Systems and Compliance reports to the Director , Animal Health Quality Management Systems and...reports and provide PQC data /line listings to US Regulatory Affairs for inclusion in Drug Experience Reports to… more
- Merck & Co. (Durham, NC)
- …resources activities while ensuring a safe work environment with optimized product quality and manufacturing processes and regulatory compliance. GENERAL PROFILE ... provides the best in class services with the final goal of delivering our high- quality vaccines to the patients around the world.With our core principle of Safety… more
- Novo Nordisk Inc. (West Palm Beach, FL)
- …Relationships Internally, the Educator Manager (EM) reports to a Region Business Director (RBD) in the Commercial Area and has direct supervisory responsibility for ... influencing diabetes and obesity care (eg, diabetes centers of excellence, quality , care management, population health, and other key departments focused on… more
- Merck & Co. (Durham, NC)
- …or review and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key ... embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development and content publishing processes in an SOP and ensure compliance Manage quality control of all NNI healthcare professional websites assuring no dead ... links, browser compatibility and other standard quality control processes Manage Web Trends tracking tool to report activity on relevant Internet sites Work with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes ... including advocating for good data governance, stewardship, data identification, and data quality to enable business outcomes. This role will consist of these… more
