- 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
- 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
- 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
- Insmed Incorporated (NJ)
- …supporting biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems , regulatory requirements (21 CFR Parts 210/211, ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for...cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into… 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
- CHRISTUS Health (Alamogordo, NM)
- …and management skills to guide design, development, and deployment of critical systems . The Director will maintain knowledge of current and emerging trends ... Description Summary: The Director Information Services will assist with creating business...duties as assigned. Requirements: Bachelor's degree in Computer Science, Management Information Systems , Business, or related field,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures for the signaling activities to ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of...improvement around development of new signal workflow/process, development of quality systems and tools, updates to templates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of all ... programs.Partner with Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution… 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)
- …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)
- …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
- 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
- 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)
- 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
- 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
- Endeavor Health (Warrenville, IL)
- …and other system modifications to reduce charge errors and denials. Works with Director of Quality Initiatives, Information Systems , and Coding Compliance ... of experience, among other factors. Position Highlights: Position: System Director , Coding-Professional Location: Warrenville, IL Full Time/Part Time: Full Time,… 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
- 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
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