- Merck & Co. (Durham, NC)
- …role in the network of life-saving medicines and vaccines. - The Associate Director , Quality Systems and Compliance provides expertise in the coordination of ... support during critical processing and manufacturing. FUNCTIONAL EXPERTISE: The Associate Director , Quality Systems and Compliance will be responsible for… more
- Merck & Co. (Durham, NC)
- … Quality Notifications (QNs), system commissioning and qualification, change control , and other key automation related processesAssisting in the development and ... Job DescriptionPosition Description Associate Director , Automation The Associate Director Manufacturing Automation is responsible for managing the team in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation ... an effective use of HEOR and RWE methods. The Director will provide HEOR and RWE strategic direction to...as early economic models, burden of illness studies, external control arms to support single arm trials, and drive… more
- Merck & Co. (Rahway, NJ)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements.-This position will lead ... management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO… more
- Merck & Co. (Rahway, NJ)
- …also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality , and our partners in the commercialization and ... regulatory environment, and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director ...the regulatory environment.Nature and Scope of Position:The Director reports to the Executive Director of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience preferred Comfortable operating in a fast-paced, environment, with a quality control focus and a documentation orientation Innate intellectual ... to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the...guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) teams on strategy development and execution.… more
- Merck & Co. (Rahway, NJ)
- …development, control strategy, and specifications-setting.-Deep working knowledge of regulatory guidance and quality standards, with experience authoring and ... to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and… 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
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... regulatory , and compliance standards. Collaborating with business and EIT...compliance controls.Monitor and test IT compliance controls for effectiveness.Remediate control deficiencies and investigate potential unlawful actions.Oversee system data… more
- Merck & Co. (Rahway, NJ)
- …Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… 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
- Insmed Incorporated (Bridgewater, NJ)
- …substance sections of regulatory filings and dossiers.Sound awareness of Regulatory , Quality Assurance, and cGMP requirementsHigh energy, innovative "can do" ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the… 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 (Thousand Oaks, CA)
- …PQ staff and executive leadership, International Quality , Quality Control , Contract Manufacturing Quality , Regulatory , Process Development, ... and/or AKTA chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Senior Quality Engineer at Insmed position reports directly to the Director of Product Quality Complaints. The primary responsibilities include managing QA ... quality complaints in regulated industry.Direct involvement in Document Control , and Deviations/CAPAs, in pharmaceutical or medical device industryThorough… more
- Merck & Co. (Rahway, NJ)
- … control systems to improve production efficiency and product quality .Collaborate with cross-functional teams, including operations, maintenance, and quality ... The Associate Specialist - Engineering Auto Eng position will report to the Director , Engineering, Automation Lead position and will be a member of the Auto… more
- Insmed Incorporated (Bridgewater, NJ)
- …and training. The Manager, US Compliance reports to the Senior Director , US Compliance.ResponsibilitiesCollaborate with US Compliance Business Partners to support ... system and/or process enhancements to support business needs and/or regulatory updatesSupport additional compliance initiatives and projectsFoster a proactive… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …onsite based role with relocation assistance eligible for selected candidate.Relationships Reports to: Director of MSAT & Quality Control Number of ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... such as residual and PCR-based assays).Strong background in analytical control strategy development and execution.Demonstrated ability to develop talent through… more
