- Merck & Co. (North Wales, PA)
- Job Description Position Description: Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease The Regulatory Affairs Headquarters ... as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other… more
- Merck & Co. (Durham, NC)
- …patients around the world with our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support a new drug ... strategic process, equipment, and qualification activities while ensuring product quality and optimized maintenance processes, regulatory compliance, employee… more
- Merck & Co. (North Wales, PA)
- …and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for ... or the device constituent of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical… 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
- 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …support talent development.Ensure adherence to all applicable regulations, guidelines, and quality standards, including cGMP, FDA, and other regulatory ... product deliverablesDevelop and implement innovative solutions to process analysis and control throughout the lifecycleAttract, lead, and develop a world-class team… 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
- Merck & Co. (Rahway, NJ)
- …procedures, Training, and SOPs for all GxP automation systems.-Integration of control systems with MES, Quality , and Batch Reporting applications.Understand ... on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot… 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
- 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. (Raleigh, NC)
- …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 centres of excellence, quality , care management, population health, and other key departments focused on… 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
- ContinueCARE Hospital at Palmetto Health Baptist (Columbia, SC)
- The Director of Quality facilitates, and manages the ongoing, hospital-wide Quality program to ensure compliance with accrediting and regulatory ... within the hospital. Monitors patient admissions and placement to ensure optimum control of infection Maintain current Quality Improvement plans, policies,… more
- Truliant Federal Credit Union (Winston-Salem, NC)
- …Credit Union. Responsible for vendor management and oversight, including execution of quality control plans and annual reviews.Develops and ensures budgetary ... and rewarded for all that they do. Purpose of the JobThe Director , Credit Administration is responsible for the overall leadership, performance, and administration… more
- Option Care Health (Bannockburn, IL)
- …to hiring, developing, and retaining a diverse workforce. Job Description Summary:The Director , Quality and Risk Management shall have oversight responsibility ... emphasis on integrating Quality Improvement and safety processes as appropriate. The Director , Quality and Risk Management reports to the VP, Quality … 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
