- Merck & Co. (Rahway, NJ)
- …and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with Health ... of CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery of high- quality...of risk and mitigation for significant issues.Ensures that all regulatory requirements are met and that systems … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data ... and reporting capabilities, incl. creating reports and dashboards of key regulatory data/metrics from across systems , leveraging technical integrations and… more
- Merck & Co. (North Wales, PA)
- …agency background packages and response to health authority questions per established business processes and systems .Collaborate with partner groups in critical ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited ... diseases and immune disorders.Summary The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific, regulatory , and business perspectives to ensure compliance with evolving ... also develop, oversee, and manage implementation of global labeling development and quality review processes, templates, metrics, and systems , while ensuring… more
- Tris Pharma (Monmouth Junction, NJ)
- …standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event, ... product quality complaintsEngages in activities to continuously assess and improve quality systems by identifying and proactively resolving quality … more
- Catalent (San Diego, CA)
- …experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality systems , deviations, investigations, CAPAs ... products and dosage forms.Must have a demonstrable record of implementing and maintaining quality systems ; laying out a strategic plan and overseeing the… more
- Merck & Co. (North Wales, PA)
- …implementation of required Quality Management System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current ... of New Modalities pipeline products to global markets.-Evaluate current and partner Quality Management Systems for seamless integration and realize synergies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business strategy within one ... escalation process and the CAPA Management Process for the respective business areas.ResponsibilitiesFacilitate the implementation of the quality strategy in… more
- BioAgilytix (Durham, NC)
- … quality oversight of the validations for all computer systems and equipment qualifications working with other departments/consultants/vendors to plan, implement ... cross-functional teams to address and resolve audit observations related to computer systems and equipmentPerform duties with minimal Quality Engineer Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the ... risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute regulatory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …metrics Focusing on mentoring, process excellence, and executionSustain Quality Systems to ensure no critical complaints or regulatory actionsProvide support ... Position Summary The Director of Quality Operations provides direct support for all Manufacturing and Quality activities. This position supports the Quality … more
- Merck & Co. (North Wales, PA)
- …It is business critical that our company receives consistent, accurate, high- quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation & ... Board (CCB) to coordinate and prioritize between our company's Business , Research Division IT Systems Owners and...clinical development programs, clinical trial processes as well as quality management systems and quality … more
- Merck & Co. (Rahway, NJ)
- …process management. Enters and updates country information in clinical and finance systems .Ownership of local regulatory and financial compliance. The position ... examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues… more
- Russell Tobin & Associates (Dublin, OH)
- …multidisciplinary teams ensuring on time, on budget, and with a focus on high- quality delivery while meeting project metrics Maintain and grow client relationships - ... work assignments to internal project teams and subcontractors Interact with regulatory agencies knowing what information to provide, when, and with appropriate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …approach, leveraging competencies, tools, and technology. Maintains responsibility for quality , performance, regulatory compliance, and patient safety related ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Atlanta, GA)
- 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. (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
- Tris Pharma (Monmouth Junction, NJ)
- …risks mitigation, etc. Collaborates with appropriate clinical, medical, quality and regulatory counterparts and others across business to provide input and ... The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to identify, evaluate… more
- Merck & Co. (Durham, NC)
- …(instrumentation, electrical, plumbing, advanced mechanical, and/or multi-stage refrigeration systems )Working knowledge of regulatory requirements in accordance ... Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business )Adapt - Develop Our People, Culture and Business Model to… more
