- Merck & Co. (Rahway, NJ)
- … Quality Management , Quality Management System Auditing, Quality Management Systems (QMS), Quality Standards, USDA RegulationsPreferred ... Compliance (IC), and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA and ICH regulations and guidelines Expertise in safety databases, call center telephony systems and quality systems Knowledge of NNI supported disease ... and Compliance, Global Safety, and centralized teams (eg, Training and Documentation, Quality , Supplier and Contract Management and Digital Enablement). This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including FDA and ICH regulations and guideline Expertise in safety databases and quality systems Knowledge of NNI supported disease states preferred (eg, ... you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers...to proactively identify and mitigate potential issues Compliance & Quality Assurance Partner with NNI Patient Safety Management… more
- Merck & Co. (Rahway, NJ)
- …into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence ... compliant supply of commercialized products for the benefit of patients. The Director of Packaging Distribution, Components and Systems COE is integral… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Strong understanding of GxP training compliance, FDA regulations, ICH Guidelines, and quality management systems Exceptional project management and ... personnel, ensuring effective learning and adherence to GxP standards Maintain learning management systems and track training completion rates to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …GxP Compliance Training and Patient Safety Operations. This role ensures that Safety/ Quality /Training processes, systems , and resources are optimized to support ... appropriate departments to assist with the implementation and optimization of safety/ quality /training systems Drive adoption of digital tools (AI-assisted case… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …schedule, within budget, per direction, and are internally consistent with group deliverable quality Systems and Data Management Responsible for gross-to-net ... methodologies, tools, and core deliverables. Relationships Reports to the Director , Sales Reporting & Forecasting. Position regularly interacts with members… more
- Merck & Co. (Rahway, NJ)
- …and maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems .Qualifications:EducationRequired Technical BS degree or ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...testing, and process validation, with a strong understanding of quality management systems and regulatory… more
- Capital One (Williamsburg, VA)
- Director , Technology (Portfolio Operations) The ideal candidate will work with senior leaders to deliver results across a broad portfolio of initiatives and is ... this mission, supports roughly 700 product, technology, and design associates. As the Director of this team, you'll serve as a strategic partner to senior leaders,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , Master Data Management (MDM) will lead a centralized team responsible for governance, stewardship, and continuous improvement of ... Team Leadership, Cross-Functional Teamwork, Data Analysis, Data Governance, Data Management Platform (DMP), Data Quality Control, Decision Making,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... the organization Develop and maintain NNI CDSE SharePoint site and operational systems and tools to ensure governance compliance Responsible for CDSE internal and… more
- Merck & Co. (Rahway, NJ)
- …maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering, ... focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team...testing, and process validation, with a strong understanding of quality management systems and regulatory… more
- Merck & Co. (Rahway, NJ)
- …maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in mechanical engineering, ... focus on autoinjectors, prefilled syringes, and other drug delivery systems . The associate director will be a...testing, and process validation, with a strong understanding of quality management systems and regulatory… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Eisai, Inc (Nutley, NJ)
- …and inspection management , issue management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) ... , issue management , and oversight of the quality management system).Conduct complex audits of sites,...Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance - Remote-Based is… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Tris Pharma (Monmouth Junction, NJ)
- …procurement strategies and operations, contract negotiations, supplier relationship management , procurement systems functionality/workflows and assurance of ... in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The … more
- Novo Nordisk Inc. (Boulder, CO)
- …to our patients Work effectively across all departments, such as Quality Assurance/ Control, Chemical Development, Program Management , Regulatory, Analytical ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …this leader.Key Responsibilities Lead and oversee all engineering management including asset/reliability, data systems /automation and ... Car-T / large-scale site and 24/7 environment.Strong knowledge of building systems (HVAC, electrical, plumbing), construction project management , and… more
